Regulatory Affairs Strategist

2 tygodni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat

We are seeking a highly motivated and experienced Regulatory Project Manager to join our team in Warsaw. In this role, you will be responsible for ensuring the development of regulatory strategies and their execution for assigned assets consistent with the strategic activities for GSK's Classic & Established Product (CEP) portfolio.

As Global Regulatory Lead, you will drive matrix team engagement for a range of CEP portfolio Assets and take ownership of the life cycle maintenance, including discontinuation of Marketing Authorizations (MAs). You will lead communication with regulatory agencies, specifically be the main point of contact with the European Medicines Agency and other European Local Health Authorities for National, Centralised and Mutual Recognition procedures products.

You will ensure that the regulatory strategy delivers the needs of the Global and regional commercial and supply chain projects, while considering the regulatory needs of the local market(s). This includes cultivating and sustaining productive relationships with internal stakeholders, including regulatory labelling, CMC, medical, commercial, supply chain, and clinical teams.

Key Responsibilities:
  • Develop and execute regulatory strategies for assigned assets
  • Drive matrix team engagement for CEP portfolio Assets
  • Lead communication with regulatory agencies
  • Ensure compliance with global/regional regulatory life-cycle requirements
Requirements:
  • Degree in Biological or Healthcare Science
  • Experience of all phases of the drug development process in regulatory affairs
  • In-depth understanding and practical experience of European Regulatory landscape and procedural requirements


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