ASSOCIATE DIRECTOR REGULATORY AFFAIRS CMC, BIOLOGICS, REMOTE

Posting Date: 15.03.2024

​

We are looking for an Associate Director Regulatory CMC to join a clinical-stage biopharmaceutical company. This position is remote (from the UK, France or Belgium). However, you will be required to visit the local offices in-person from time to time.

​

The AD Regulatory Affairs CMC supports the development CMC activities for a portfolio of novel biological drug candidates for treatment of haematological disorders. This position will be collaborating across the business and with external partners on Regulatory CMC matters content, strategy. It will oversee submissions and respond to Health Authority questions. The role will report to a Director Regulatory CMC.

​

Responsibilities:

​

• Serves as Regulatory Affairs CMC lead or support for assigned product/s for all RA CMC activities including the development of Regulatory CMC strategies.

• Ensures on-time and high-quality submissions for biologics (INDs, IMPDs, CTAs, NDA/BLAs, MAAs). This includes the planning, coordinating, writing, and tracking the Regulatory CMC dossier as well as writing responses to Regulatory CMC related inquiries from Health Authorities and supporting the preparation for HA meetings on Regulatory CMC matters.

• Provides Regulatory CMC guidance for development programs, assesses and communicates Regulatory CMC requirements and develops best practices to ensure compliance with applicable regulations and guidelines. Represents Regulatory CMC on working groups and teams.

• Provides regulatory and scientific expertise to review CMC source documentation in support of dossiers.

​

Requirements:

​

• BSc in a scientific discipline or advanced degree.

• 7+ years of Regulatory CMC experience.

• At least 5 years of RA CMC experience with biologicals required.

• Project management, creative problem solving and ability to perform independently required.

• Understanding of scientific principles and ability to interpret regulatory requirements.

• Experience in writing and preparation of CMC sections of submissions - IDNs, IMPDs and BLA/NDAs and/or MAA sections in eCTD format.

• Direct experience participating in Health Authority interactions and meetings.

• Excellent oral and written communication skills. Ability to influence cross-functionally at all levels of the organisation.

• Sound judgement, solid sense of accountability and strong attention to detail.

​

Candidates must be authorised to work in the UK or the EU.

​

Our client is an Equal Opportunity employer and an inclusive company that believes that diversity drives innovation. The company encourages a merit-based culture of mutual respect and support.

On offer is a competitive salary and benefits package.

​

Get in touch for more information or click on the apply button to send us your CV or register your interest.

​