In a nutshell
Position: Regulatory Affairs Manager - Biosimilars
Location: Madrid (on-site)
Experience: 5+ years in Regulatory Affairs within biotech/biopharma
Want to know more?
INSUD PHARMA operates across the entire pharmaceutical value chain, bringing specialist knowledge and experience in scientific research, development, manufacturing, sales, and commercialization of a broad range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value in both human and animal health.
Our activities are organized in three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries. We are committed to innovation and sustainable development to deliver solutions that positively impact global health.
Ready to be a #Challenger at INSUD PHARMA?
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 global, cross-functional teams.
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 deficiency letters.
* Prepare, review, and approve regulatory submission documents (briefing packages, IBs, INDs, CTAs, MAAs, etc.).
* Manage external consultants and vendors for regulatory activities.
* Support product launch activities, ensuring 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 CMC documentation.
* Drive digitalization and the use of computerized systems within the department.
The challenge!