Associate Director, Global Regulatory Affairs
- Experience Level
- Senior Management
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.
Youll 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.
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