Associate Director of Global Regulatory Affairs
Bay Area or Remote
This is an exceptional opportunity to join a global biotechnology business at an exciting stage of product development. The successful candidate will play a pivotal role in providing regulatory advice on global requirements across all functional areas including early research, CMC, device, nonclinical and clinical trials from early stage (IND/CTA) through to NDA/BLA and ongoing submission lifecycle management.
· Work alongside global and functional team to provide regulatory advice on global requirements.
· Reviewing of submission documents, ensuring regulatory compliance and consistency with company and submission strategy.
· Manage submission strategy for regulatory projects and management of document filing and archiving systems.
· You’ll act as the primary publishing vendor interface, ensuring submission documentation is compliant with health authority requirements and guidance globally.
· Implement new regulatory systems as required and devise new processes and operating procedures.
· Involvement in regulatory project management activities, acting as the primary regulatory lead to provide support and strategy as required.
· Reviewing clinical, CMC and safety documentation to ensure compliance and completeness throughout the authoring and finalization processes.
· Coordinate safety reporting, working closely with pharmacovigilance to ensure tracking and safety reporting systems are in place.
· Candidate should ideally be educated to Bachelors or Masters degree in a relative subject
· You will hold at least 5 years’ experience within a similar regulatory position.
· Previous experience gained within drug development approval stages is essential.
· Experience of managing large, global submissions (EMA, FDA).
· Solid understanding of FDA, EMA, PDMA, ICH documentation requirements.
· You will hold excellent communication skills and the ability to manage and influence others.
· First class project & time management skills with the ability to work to strict deadlines.
· Experience with Class 3 Devices would be a major advantage but not essential.
To be considered for this position or to find out further information on the role please e-mail your resume to Gary.Crawley@cpl.com.