Regulatory Affairs Lead

vor 1 Tag

Frankfurt am Main, Hessen, Deutschland Grifols Vollzeit
About the Role

We are seeking a highly skilled Regulatory Affairs Lead to join our team at Grifols. As a key member of our regulatory affairs department, you will play a crucial role in ensuring that our products meet the highest regulatory standards.

Job Description

The Regulatory Affairs Lead will be responsible for coordinating European marketing authorization maintenance and regulatory life cycle management of assigned products. This will involve preparing regulatory documentation, submitting dossiers to regulatory authorities, and coordinating with external partners as needed.

You will also have the opportunity to serve as the product primary contact with regulatory authorities, ensuring the licensing and maintenance of product marketing authorizations. Additionally, you will support the preparation and submission of required documentation, including responses to questions from regulatory authorities.

The successful candidate will possess excellent communication and organizational skills, with a strong attention to detail and ability to work effectively in a team environment. You will also have a deep understanding of EU regulatory requirements and laws, as well as experience with eCTD and related tools.

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
  • Submit dossiers to regulatory authorities, including PEI/BfArM or other competent authorities
  • Serve as product primary contact with regulatory authorities, ensuring licensing and maintenance of product marketing authorizations
  • Support preparation and submission of required documentation, including responses to questions from regulatory authorities
Requirements
  • University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar)
  • At least 4 years of relevant experience in European pharmaceutical Regulatory Affairs, ideally in biological products / plasma derived products
  • Excellent knowledge of German national and EU regulatory requirements and laws
  • Experience with eCTD and related tools desirable
  • Qualification as Information Officer according to §74a AMG (desirable)
  • Fluent German and English language skills
Benefits

We offer a competitive salary and benefits package, including:

  • $100,000 - $120,000 per year, depending on experience
  • Ongoing training and professional development opportunities
  • A dynamic and supportive work environment

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