Regulatory Affairs Specialist

Vor 4 Tagen

Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit

About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Grifols. As a key member of our regulatory team, you will be responsible for ensuring compliance with European regulatory requirements and maintaining the company's marketing authorizations.

Key Responsibilities

  • Coordinate European Marketing Authorization maintenance and regulatory life cycle management of assigned products.
  • Prepare regulatory documentation in collaboration with colleagues at Grifols Headquarters and/or manufacturing sites in close cooperation with RA Biopharma.
  • Coordinate submission of these dossiers to the appropriate regulatory authorities and distribution to external RA partners in the concerned countries as needed.
  • Coordinate compilation of product information according to national and European laws and regulations for the products assigned.
  • Coordinate and contribute to label development and release of packaging materials.
  • Serve as the product primary contact with regulatory authorities to ensure the licensing and maintenance of product(s) marketing authorization(s).
  • Coordinate the timely preparation and submission of national documentation for nationally marketing authorizations, including responses to questions from regulatory authorities.
  • Collaborate with Global Regulatory Affairs, Pharmacovigilance, local Quality and Medical Affairs in the preparation and submission of required documentation.
  • Support maintaining regulatory intelligence database regarding national and EU regulatory requirements through review of publications, attendance at seminars and direct communication with outside regulatory personnel, including regulatory authorities.
  • Participate in review of promotional materials and ensures compliance with European regulations and guidelines.
  • Support conduct of authority meetings and attend seminars and industry trade association meetings, and where appropriate, serves as company representative on committees and task forces.

Information Officer Responsibilities

  • Verify that the scientific information about the medicinal product complies with the current status of the marketing authorization.
  • Control and approve the mock-ups of new packaging material (labeling and package insert) to ensure that it is the agreement with the authorized product information.
  • Release the new/updated SmPC (Fachinformation) for publication and distribution and blocks the old superseded SmPC.
  • Control and approve the promotional material with regard to the prohibition concerning deception.
  • Responsible for compilation and revision of SOPs describing the release procedures.

Requirements

  • You have a University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar). A Master's Degree is also required.
  • You have at least 4 years of relevant experience in European pharmaceutical Regulatory Affairs, ideally in biological products / plasma derived products.
  • You have good knowledge of German national and EU regulatory requirements and laws.
  • You have experience with eCTD and respective tools desirable.
  • You have a qualification as Information Officer according to §74a AMG (desirable).
  • You possess good computer skills (MS Office and RA related software).
  • You possess good communication and organization skills.
  • You are a structured, diligent, self-motivated and results-oriented person, with high attention to detail.
  • You are a team player, able to collaborate with cross functional teams to achieve the objectives.
  • You speak fluent German and English.

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