Vacancy Description
Regulatory Affairs Manager - Biosimilars
Location: Madrid (on-site)
Experience: 5+ years in Regulatory Affairs within biotech/biopharma
Key Responsibilities
- Monitor changes in the regulatory landscape, identify their impact, and propose solutions to maintain compliance.
- Define regulatory strategy for each product in coordination with Management and Business teams.
- Build strong collaborative partnerships with internal and external teams to ensure organizational success and patient safety.
- Identify and mitigate regulatory risks, adapting strategies to evolving regulations and Health Authority feedback.
- Interpret and communicate legislative changes that affect product registration, manufacturing, or development.
- Support the review of license and quality agreements for targeted geographies.
- Lead engagement with Health Authorities during Scientific Advice procedures and responses to d...
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