|Sector||Pharmaceuticals & Biotechnology|
Execution of European Regulatory CMC strategies, submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD’s, MAA’s,…) to regulatory agencies. Potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides. Depending on experience, may act as CMC liaison with regulatory authorities to discuss and define submission contents and strategies.
Preparation of CMC information for submission to EU regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans. Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff,… in order to discuss and define regulatory applications (Quality Module, Responses, Commitments. Depending on experience, may act as CMC representative in formal meetings and teleconferences with regulatory authorities.
Life Cycle Teams and compliance of commercial products.
May operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams.
EDUCATION & EXPERIENCE:
Scientific degree in a relevant subject (minimum PharmD or science related BSc or MSc)
An experienced regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development and/or biopharmaceutical manufacturing and/or specific regulatory domain (3-5 years prior international regulatory with experience in CMC or in Quality Assurance). Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects.
Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.
Candidate is required to have a recognized demonstration of
- Leadership skills, influencing and persuading skills
- Excellent cross-cultural awareness and understanding
- Fluency in the English Language is essential
- Excellent communication, interpersonal and relationship building skills
- Collaborative team player
- Excellent planning, organizational and project management skills
- Proactive and flexible