Regulatory Affairs Biosimilars Manager

Robert Walters is looking for a Regulatory Affairs Biosimilars Manager for an important pharmaceutical company in Barcelona.

Our client is hiring a Regulatory Affairs Biosimilars Manager to coordinate the regulatory affairs activities with the Headquarters for all related Biosimilars products pre and post approval phase, in regulated markets worldwide.

Your responsibilities include, but are not limited to:

• Understands Biosimilars EU/US regulations and guidance.

• Provide regulatory support to the internal R&D team and external customers during development program and product life cycle

• Collaborate closely with Regulatory CMC on related filing content, strategies, and risk mitigations.

• Coordinate the preparation of the briefing package and submission of SA applications to EMA.

• Submission of new MAAs, post approval changes and renewal applications for the client and third-party customers worldwide.

• Assist during Dossier Due Diligence process with potential third-party

• Regulatory point of contact for third party clients.

• Regulatory compliance check of documents and evaluation of change controls

• Maintain compliance for assigned products (PSURs, HA correspondence, product label updates, adheres to SOPs…)

• Provide RA support to the BD department

• Internally interact with different stake holders to coordinate and ensure successful product launch.

• Coordinate QTA and SDEA discussions with clients

• University degree in scientific discipline (Pharmacy, Biology, Chemistry, etc)

EDUCATION:

• Master’s degree in Pharmaceutical industry and/or regulatory affairs is preferred

• Minimum of 3-year experience in Regulatory Biosimilars

• Experience in global matrix environment preferred

• Knowledge on Quality Assurance and Pharmacovigilance is preferred

• Advanced written and spoken English

If you are interested in a new opportunity, you can send me your cv to fatima.amat@robertwalters.com