In a nutshell ?
- Position: Regulatory Affairs Manager
- Location: Madrid (on-site)
- Experience: 5+ years in Regulatory Affairs within biotech/biopharma

Want to know more? ?

BioNaNopharma is a leading biotechnology company committed to innovation and the sustainable development of advanced pharmaceutical solutions. Our multidisciplinary team is dedicated to the development, manufacturing, and commercialization of innovative medicines and biosimilars, making a real impact on global health.

Ready to be a #Challenger at BioNaNopharma? ?

What are we looking for? ?

We are seeking a Regulatory Affairs Manager to lead the regulatory strategy for our innovative and biosimilar products, ensuring compliance and collaborating with integral, cross-functional teams.

Key Responsibilities:
- Monitor changes in the regulatory landscape, identify impacts, and propose solutions to maintain compliance.
- Define regulatory strategy for each product in coordination with Management and Business areas.




- 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 affecting 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 deficiency letters.
- Prepare, review, and approve regulatory submission documents (briefing packages, IBs, INDs, CTAs, MAAs, etc.).
- Manage external consultants and vendors in regulatory activities.
- Support product launch activities and ensure regulatory risks are managed with appropriate action plans.
- Organize the regulatory submission schedule and coordinate with Regulatory Affairs teams.
- Participate in product plan development, regulatory strategy, and

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