Open Positions

Regulatory Affairs Country Manager
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Our client is an international pharmaceutical company with extensive portfolio of OTC, supplements and other related products.

Main Accountabilities

  • Enabling Commercial Strategy – ensuring development of local regulatory strategy for new product registration and license maintenance, fully aligned to business needs
  • Ensuring compliance with all legal obligations
  • Ensuring vigilance for the local product portfolio of the company for all types of products (pharmacovigilance, medvigilance, materiovigilance, etc.) and full compliance with QA requirements
  • Overseeing and ensuring establishment and maintenance of quality; ensuring compliance with GDP and supervising all relevant local quality operations and systems including local batch release and audits etc.
  • Ensuring that local QMS is in place and maintained in line with relevant local and EU requirements, as well as the global company guidelines and principles
  • Effectively managing expectations across a broad range of business stakeholders, employing high quality communications in all interactions
  • Continuing to build strong relationships with Regulatory Authorities, Trade Associations & Key Opinion Leaders, forming a go-to network for strategy development and problem solving
  • Ensuring communication with state health authorities in the area of all product types in the local portfolio
  • Leading and effectively managing the regulatory, quality, safety team in Romania and ensuring smooth operations with the relevant consultants in Moldova
  • Managing local Regulatory/Safety /Quality budget and ensuring it is regularly discussed and aligned with relevant stakeholders

Professional Skills

  • Educated to degree level within life sciences. Pharmacist degree would be a plus
  • Substantial experience (6+ years) working within regulatory affairs, ideally within OTC sector, and good industry insight
  • Experience includes Medicines and Medical devices; with Medicines experience spanning new MAAs (with awareness of National Procedures/DCP/MRP), as well as management of line extensions and licence maintenance activities
  • Strong experience (2+ years) within Quality affairs for medicines and medical devices and cosmetics. Good understanding and experience with GMP & GDP and ISO requirements
  • Extensive involvement in the generation/review of product claims and advertising materials across product types
  • Experience with Pharmacovigilance and Materiovigilance systems
  • Strong commercial understanding and a ‘sales enabling’ regulatory mindset
  • Able to prioritise in line with business needs, managing stakeholders and expectations
  • Fluent in English

Personality Profile

  • Passionate and energetic, with a “can do” mentality
  • Able to handle multiple tasks in a fast-paced and changing environment, while having a hands-on approach, and entrepreneurial mindset
  • Capable to work independently and self-start to define a path and gather knowledge
  • Takes initiative, looks for opportunities to do more, and takes risk when justified
  • Displays thoroughness in analysis and follow-up
  • Generates creative solutions to problems faced and is able to make decisions in ambiguous situations
  • Demonstrates empathy and respect for people, takes responsibility, and communicates with confidence and tact, confronting issues appropriately.

Regulatory Affairs Country Manager



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Client Service Manager
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Our client is a company active in the distribution and transportation of liquid gas. Position is based in Bucharest.

Main Accountabilities

  • Trains, supervises, motivates, and evaluates the subordinated team (up to 9 people), in order to deliver a high standard of customer service
  • Monitors the activity of the client service team and their specific activity, namely registering orders, complaints, debt collection, preparation of reports, registration of contracts, price changes and other tasks required or specified in the company’s internal procedures
  • Understands clients’ needs and provides supports, thus strengthening existing relations with all customers (B2B, B2C). Addresses client concerns and issues promptly and professionally
  • Designs, implements, and monitors procedures and standards related to the specifics of the role
  • Prepares analysis and reports on the results of the department-specific activities
  • Reports the unjustified exceedances of the contractual terms and proposes measures and solutions
  • Permanently monitors deliveries to customers, deadlines, and terms (credit limit, verifying / updating prices). Can propose appropriate “client packages” by business segments
  • Follows the transport routes and proposes improvements for the increase in efficiency and the use at optimal capacity of all the means of transport managed for the distribution activity
  • Supervises the analysis reports of the commercial contracts made by the team and proposes new reports to ensure a better monitoring
  • Supports the legal team with the necessary documents for legal actions
  • Participates in the calculation and implementation in the computer system of the credit limit and payment terms for the company’s clients
  • Carefully checks all the necessary documentation, the justifications for obtaining the credit limits; ensures that all documents are approved by the decision makers within the company

Professional Skills

  • Relevant experience in customer service of minimum 3 years
  • Strong project managements and multitasking abilities
  • Very good leadership, problem solving, and planning skills
  • Proficient in oral and written communication
  • Organisational capabilities and attention to details
  • Background in complaints management
  • Able to work in a very dynamic environment, managing a large volume of clients-related tasks

Personality Profile

  • Can-do and optimistic attitude
  • Team player with very good interpersonal skills, able to motivate and influence all stakeholders
  • Accountable for his/her actions
  • Proactive, persuasive person
  • Honest and upstanding, with strong moral values
  • Fluent in English; knowing another foreign language represents a plus

Client Service Manager



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Business Development Manager Renewable Energy
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Our client is a leading European operator of power generation assets (Hydro, Wind, PV, Gas) in Europe. Position is based in Bucharest.

Main Accountabilities

  • Building up market know-how and market development strategies
  • Supporting and leading the business development process (organic and inorganic growth) that is consistent with the vision and strategy of the European organisation
  • Ensuring legal representation and commercial activities of the projects
  • Providing stakeholder management in Romania including ministries, institutions, authorities and agencies, local government, landowners as well as all other relevant parties within the private sector
  • Participating in the decision-making process of the different commercial operations regarding new business, as well as agreements with partners, subcontractors, or providers
  • Being responsible for maintaining profitability (including the optimisation of commodity trading) and creating profitability calculations and coordinating these within the group units
  • Tracking and monitoring all the investments
  • Ensuring that the actions of the company are compliant with legal and regulatory requirements and with internal policies and company standards
  • Participating in the development of the public relation related activities
  • Ensuring timely and accurate reporting and analysis as requested by the management team

Professional Skills

  • Experience in the Romanian power and electricity market ideally with knowledge in, but not limited to, the renewable energy (wind and photovoltaic) segment
  • Experience in managing a business in the power and electricity market
  • Experience in efficient work in corporate and global structures, in an international environment
  • Previous relevant experience in identifying projects in the energy industry and in developing new projects
  • Experience in commercialising energy products (electricity market), commercial management and supervising power generation operations
  • An in-depth understanding and knowledge of the Romanian energy market in terms of the local law, relationships with local authorities and government agencies
  • Ability to build and develop relationships with local and national authorities in the industry
  • Client management excellence approach
  • Solid management experience with a leadership approach is mandatory
  • Innovation and technical excellence
  • University Degree in Electrical Engineering with strong Business Development experience and profile or University Degree in Management with experience in management of renewable energy production
  • MBA would be an additional asset
  • Fluent in English, German is an advantage

Personality Profile

  • Taking initiative and driving for results
  • Decision maker with the ability to get things done
  • Being a team player and with a spirit of belonging
  • Open minded professional approach with strong international focus
  • Corporate experience and entrepreneurial approach
  • Excellent communication abilities and superior organisation and leadership skills
  • Analytical and conceptual mind with strong strategic planning abilities
  • Creativity and flexibility to cover the customer needs
  • Strong organisational skills, proven track record in building effective structures in a competitive environment
  • Ability to operate comfortably, especially with executive level management and influential local entities
  • Building and affiliate network effectively with and outside the organisation
  • Openness and flexibility, willingness to learn
  • Multi-tasking – the ability to perform several projects simultaneously

Business Development Manager Renewable Energy



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Regulatory Affairs Project Manager
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Our client is an international pharmaceutical company providing OTC, supplements and other related products.

Main Accountabilities

  • Ensuring the regulatory compliance, appropriate licensing, marketing, and legal compliance of the products in the assigned portfolio
  • Handling NPD and Life Cycle Management activities for medicinal products, medical devices, food supplements and cosmetics, as part of the company’s portfolio
  • Enabling Commercial Strategy and managing regulatory submissions: development of local regulatory strategy for new product registration & licence maintenance and relevant submissions, fully aligned to business needs. Actively contributing to and defining claims- support rationale, to obtain the strongest commercial platform possible
  • Managing new registrations, variations, renewals, post approval commitments, RFIs etc
  • Preparing documentation for submissions and working in the relevant systems
  • Managing regulatory submissions and ensuring timely approval
  • Reviewing the regulatory approval of packaging and promotional materials, claims, artwork
  • Managing promotional materials and VISAs and other relevant health authority approvals for the assigned brands
  • Analyzing the RA information and providing regulatory intelligence regarding Romania/Moldova and collaborating closely with consultants in Moldova for industry insight
  • Working cross-functionally with central and local teams (regulatory, quality, safety, marketing, innovation, supply, sales etc) for pipeline projects, including product launches, product changes, promotional materials, artworks, labelling etc
  • Keeping abreast of European and National legislation
  • Networking and communicating with relevant authorities, key bodies, and associations regarding new MAA, renewals, licenses, variations, and cancellations for assigned products

Professional Skills

  • Educated to degree level within life sciences. Pharmacist degree would be a plus
  • Experience (3+ years) working within regulatory affairs, ideally within OTC sector, and good industry insight
  • Experience with Medicines and Medical devices and Food supplements. Experience with Biocides and Cosmetics would also be beneficial
  • Involvement in the generation/review of product claims and advertising materials across product types
  • Good commercial understanding and a ‘sales enabling’ regulatory mindset, identifying opportunities and building a regulatory strategy which aligns to business needs
  • Able to critique data, assess probability of success and adapt based on strength of position
  • Good negotiation and communication skills, able to adapt style to audience (Regulatory Authorities, notified bodies, policy makers, etc)
  • Capable to foster collaboration with other functions and departments, at all levels, and to act as an equal partner and valued voice in all interactions
  • Fluent in Romanian and English

Personality Profile

  • Passionate and energetic, with a “can do” mentality
  • Able to handle multiple tasks in a fast-paced and changing environment, while having a hands-on approach, and entrepreneurial mindset
  • Capable to work independently and self-start to define a path and gather knowledge
  • Displays thoroughness in analysis and follow-up
  • Generates creative solutions to problems faced and is able to make decisions in ambiguous situations
  • Demonstrates empathy and respect for people, takes responsibility, and communicates with confidence and tact, confronting issues appropriately

Regulatory Affairs Project Manager



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I consent to be included in Stein & Partner’s active database until I withdraw my consent, and to be contacted by Stein & Partner for future positions that could be of interest to me
I want to receive Stein & Partner’s periodical newsletters via email
Human Resources Manager
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We are looking for a Human Resources Manager for our client – a global automotive supplier, located in Brasov area.

Main Accountabilities

  • Organising, leading and planning the HR department including taking the responsibility for the budget of the department
  • Developing and implementing best practices for hiring and for talent management
  • Developing organisational and personnel structure in order to assure reaching the targets within the set time lines and according to economic efficiency
  • Assuring a positive and motivational working environment while promoting team spirit and cooperation
  • Preparing and conducting interviews for the top management positions
  • Assuming ultimate responsibility for HR operations such as: labour contracts and disciplinary measures
  • Initiating corporate changes while evaluating and taking into considerations the overall impact on the organisation and on the financial result (quantitative evaluations)
  • Actively supporting the departments to implement leadership and behavioural guidelines within the company
  • Providing coaching support for the employees throughout change processes within the organisation
  • Contributing to the development of the application and selection process within the company and assuming responsibility for its implementation and results

Professional Skills

  • University degree (Human Resources, Business Administration or related)
  • Minimum 10 years of HR experience in a multinational production company, ideally from the automotive industry
  • In-depth knowledge of labour law and HR best practices
  • Ability to architect strategy along with leadership skills
  • Good planning, organising and follow-up skills
  • Coach certificate, would be a plus
  • Fluency in English, German would be a plus

Personality Profile

  • Active, energetic and highly motivated to drive change throughout the organisation
  • Very good communication, influential and negotiation skills
  • Strategic approach
  • Ability to evaluate and make decisions
  • Highly organised and accurate, nevertheless flexible and quickly reactive, while respecting the deadlines
  • Ability to develop teams, to collaborate and to influence

Human Resources Manager



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Senior Manufacturing Engineering Manager
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We are looking for a Senior Manufacturing Engineering Manager for our client – global automotive supplier, located in Brasov area.

Main Accountabilities

  • Designing and implementing best practice production engineering; planning vision, strategy, policies, processes and procedures to aid and improve operational performance
  • Driving continuous improvement activities in quality, cycle times, process improvement, machine availability through lean techniques and value engineering to enhance the capability of existing processes and remove waste
  • Developing and maintaining project plans and budget profiles to ensure delivery of milestones to agreed cost targets and timescales
  • Managing and leading the team, ensuring adequate staffing levels and ensuring the delivery of the People Strategy within the area of accountability
  • Motivating and coaching the team to operational success
  • Developing, implementing and follow-up on key performance indicators (KPIs) for each area of responsibility
  • Monitoring the completion of tasks and ensuring good performance and record on appropriate systems
  • Reviewing, implementing and updating company records e.g. training matrices, performance reviews, risk assessments, processes and procedures
  • Ensuring that the function operates in accordance with any health, safety and environmental policies and procedures to ensure the safety and wellbeing of staff and visitors
  • Liaising and communicating with other departments, customers, suppliers and other service providers

Professional Skills

  • University degree (Engineering/ Manufacturing specialisation or related)
  • Minimum 10 years of experience, preferably in a multinational production company
  • At least 3 years’ experience of working in automotive industry and in a similar position;
  • Significant experience in a high-volume manufacturing environment, preferably automotive
  • Expertise in Six Sigma/Lean Manufacturing projects implementation
  • Experience of managing and motivating a team and driving it to performance, having a native leadership approach
  • Very good planning, organising and follow-up skills
  • Fluency in English, German would be a plus

Personality Profile

  • Excellent interpersonal, team management and leadership skills
  • Ability to work in a diverse and dynamic environment
  • Good communication and interpersonal skills
  • Analytical approach with the ability to present data effectively and problem-solving skills
  • Negotiation skills
  • Open to change and with proven ability to adapt to a high-pace and changing environment

Senior Manufacturing Engineering Manager



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Senior Quality Manager
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We are looking for a Senior Quality Manager for our client – global automotive supplier, located in Brasov area.

Main Accountabilities

  • Managing and implementing a best practice quality vision, strategy, policies, processes and procedures to support and improve operational performance
  • Contributing to the implementation of new business initiatives and projects and review and communicate the impact on Quality activities
  • Ensuring that all in-house systems and procedures are constantly updated, revised and modified to meet the needs of external certification bodies supervising the implementation of internal quality procedures throughout the overall process in the company at all times and at all levels
  • Championing a program for the implementation and sustainment of a continuous improvement culture; establishing an action plan for improving quality
  • Undertaking internal and process audits of the Quality Management System (QMS)
  • In conjunction with the Supplier Quality Assurance function, reducing the effect of non-conforming supplier materials on the production area quality by performing root cause analysis and solving problems
  • Responding to customer complaints putting in containment actions, full analysis, error proofing, and implementing short and long-term countermeasures
  • Managing the relationship with the suppliers to resolve quality issues and act as a point of contact for warranty issues on client side
  • Managing the Quality Engineers and Technicians in the sign-off of parts and the resolution of internal/external quality concerns
  • Developing a comprehensive and traceable training program for the quality team in all aspects of the quality system and application and update of procedures
  • Identifying and deploying the technical skill sets, resource levels and systems to deliver projects, including the engagement of external resources as required
  • Developing, implementing and managing key performance indicators (KPIs) for each area of responsibility and assess ongoing performance of direct reports
  • Monitoring the completion of tasks and ensure good performance and record on appropriate systems
  • Ensuring that the function operates in accordance with any health, safety and environmental policies and procedures to ensure the safety and wellbeing of staff and visitors
  • Managing, coaching and developing a high performing Quality Operations team that meets agreed objectives and which delivers best practice results, added value and continuous improvements and ensuring adequate staffing levels
  • Responsible for achieving budget and forecast; reporting on achievement of targets and identifying any actions required
  • Working collaboratively, negotiating and engaging with key stakeholders to facilitate delivery and compliance with the Quality strategy
  • Communicating with stakeholders the impact of market change and potential effects on engineering design and development. Recommending solutions without compromising quality or service while optimising cost
  • Working as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimise results and improve quality of delivery, in line with quality standards requirements delivery in line with Company and Customer requirements

Professional Skills

  • University degree (Engineering or Business/Commercial specialisation or related)
  • Minimum 10 years of experience, preferably in a multinational production company
  • At least 3 years’ experience of working in the automotive industry
  • Significant experience in a high-volume manufacturing environment, preferably automotive
  • Experience of working in Quality Assurance
  • Previous experience in implementing Six Sigma/ Problem solving processes. Lean Manufacturing – would be a plus
  • Ability to manage the relationship with customers and suppliers
  • Inquisitive approach with interest in staying up to date on any changes that may affect the supply and demand of needed products and materials
  • Good planning, organising and follow-up skills
  • Fluency in English, German would be a plus

Personality Profile

  • Excellent leadership and management skills
  • Excellent interpersonal skills with ability to grow and develop large teams
  • Ability to manage a variety of cross-functional and cross-country project team
  • Continuous improvement mindset
  • Excellent written, verbal and presentation skills
  • Excellent organisational and follow-up skills
  • Competent in problem solving, team building, planning and decision making
  • Commercially aware

Senior Quality Manager



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