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Regulatory Compliance Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Biogen. As a key member of our global regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.
Key Responsibilities- Develop and implement regulatory strategies to support the development and approval of new products.
- Collaborate with cross-functional teams to ensure regulatory compliance and provide guidance on regulatory matters.
- Interface with regulatory authorities and CROs to support submissions and applications.
- Support the development of US labels and ensure implementation of regulatory requirements.
- PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs; MS with 4+ years; BS with 5+ years.
- Knowledge and understanding of applicable regulations and experience in interpretation of regulations, guidelines, and policy statements.
- Excellent operational skills including planning, organizing and ability to represent the department in project teams.
- Ability to work independently with minimal direction and to work well within cross-functional teams.
- Solid oral communication and writing skills.
- Develops collaborative relationships to facilitate the accomplishment of work goals.
- Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Biogen offers a competitive compensation package, including a base salary range of $100,000 - $162,000, as well as opportunities for professional growth and development. We are committed to building a diverse and inclusive workplace culture that reflects the communities we serve.
