Position
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 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.
* 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.
Requirements
* University degree in Health Sciences (preferably Pharmacy); degrees in Chemistry, Biology, Biochemistry, Veterinary or similar are also 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.
Benefits
* Permanent contract
* Professional development & continuous training
* International and multidisciplinary environment
* Innovative projects with high impact on health
Equal Opportunity Statement
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.
#J-18808-Ljbffr