Regulatory Regional Coordinator
- Warsaw, Poland
Site Name: Warsaw
Posted Date: Nov 30 2020
GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with healthcare system participants, focusing on dialogue and transparent cooperation.
We are currently transitioning and streamlining business operations in line with future growth strategy, so we are looking for several people to join our Partnership Markets team in Warsaw, Poland. Regulatory Coordinator will take care of operational activities to support Partnership Markets in the Europe Mid-Size Cluster Region, including coordination of aligned Global Regulatory Platform (GRPD) activities and oversight of 3rd party partners.
- Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with GRPD and 3rd Party Service Provider and to support regulatory submissions to local regulatory agencies.
- Effective planning and tracking of regulatory activities for defined markets.
- Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning.
- Ensures that GSK product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labelling are compliant with MA and with regulatory requirements and available in local language for Health Care Practitioners.
- Co-ordinates the completion of local language translations by 3rd Party CRO (Product Information, regulatory submissions and agency responses and market communications).
- Co-ordinates responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
- Co-ordinates with GRPD the management of product registration documents and agency correspondence in regulatory databases and repositories.
- Ensures that responses to Regulatory agencies regarding product quality and safety issues are made in an expeditious manner in accordance with company procedures.
- Provides considered regulatory advice, leadership and expertise to commercial and to other cross functional groups.
- Builds and maintains effective relationships with internal regulatory, quality, commercial, & supply chain groups.
- Degree in scientific discipline (life sciences / pharmacy / professions aligned to medicine).
- Min. 4 years of relevant experience in Regulatory Affairs.
- Knowledge of the policies and regulatory climate in Europe.
- Experience gained across various markets is preferred.
- Experience of working effectively in a matrix across functions.
- Effective collaboration and negotiation with regulatory agencies.
- Work in complex regulatory environment. Able to anticipate possible changes in the regulatory environment (relating to product development, NPI, and market access) proactively, to monitor their implementation, to assess and communicate possible risks and to prepare the mitigation strategy.
- Fluent English language skills (speaking and writing).
- Well-developed and demonstrable skills working as a member of a multi-functional team.
- Ability to multi task and excel in cross-functional settings and to manage multiple issues in a fast-paced environment.
- The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management.
- Challenging and interesting job in one of the leading global healthcare companies.
- Access to newest technologies and solutions.
- Possibilities of development within the role and company's structure.
- Friendly work environment and great atmosphere in our teams.
- Wide offering of company benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, recognition awards for additional achievements, flexible working hours, partly home office).
- Corporate culture based on our values: patient focus, integrity, respect and transparency.
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