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Senior Director Regulatory Affairs
4 weeks ago
We're partnered with a growing innovative biotech who are leaders in creating cutting-edge therapies with the potential to treat cancer. Their leading development programs utilize a unique antibody format that can target tumours through multiple mechanisms. With their continued growth, they are now looking for a Senior Director of CMC Regulatory Affairs to join their team.
Requirements:
- Experience with CMC regulatory affairs in an industrial setting
- Candidates must have led BLA and MAA submissions of Biologics products globally to competent authorities (US, EU and ROW) (not just been involved)
- Proven leadership/ management skills of small teams
- Experience with antibodies ideal
Responsibilities :
- Preparation, Review, and Approval of CMC Regulatory Filings
- Lead the preparation and regulatory submission of CMC sections for regulatory filings (e.g., IMPD/IND/MAA/BLA).
- Oversee CMC Regulatory Affairs Strategy: develop and implement CMC regulatory strategies for the company’s product candidates, including strategies for IND/CTA/MAA/BLA submissions, clinical trial design, and regulatory interactions.
- Management and Coordination of CMC Regulatory Activities
- Lead the selection, evaluation, and monitoring of contractors for CMC regulatory affairs activities.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
