Regulatory Affairs Manager - Biosimilars

Location: Donostia / San Sebastián

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!
Oversee the preparation and submission of regulatory documentation.
Coordinate regulatory strategy with R&D, QA, QC, and Production teams.
Lead negotiations and presentations with regulatory agencies.
Manage regulatory information and ensure data integrity.
Actively participate in scientific committees and project teams.

What do you need?
University degree in Health Sciences (preferably Pharmacy; degrees in Chemistry, Biology, Biochemistry, Veterinary or similar will also be considered).
5+ years of experience in Regulatory Affairs within biotechnology, biopharma, or biosimilars.
In-depth knowledge of pharmaceutical legislation, GMP, and ICH guidelines.
Fluent in Spanish and English (other languages are a plus).
Advanced skills in Microsoft Office (Word, Excel, PowerPoint, Project) and regulatory software.
Willingness to travel.
Inspiring, influential, results-oriented with excellent communication skills.

Our benefits!
Permanent contract
Professional development & continuous training
International and multidisciplinary environment
Innovative projects with high impact on health
What’s the selection process like? ️
Initial contact by phone or email.
1–2 interviews (virtual and/or on-site) with HR and technical teams.
Ongoing updates throughout your recruitment process.

Not the right fit for you?
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#Insud Pharma #Challenger #Insuder #Insud Talent

COMMITMENT TO EQUAL OPPORTUNITIES
At INSUD PHARMA, we promote gender equality and do not discriminate based on ethnicity, religion, sexual orientation, disability, or any other condition. We firmly believe that diversity and talent drive innovation and growth.