Reference Number: JO-2106-470029
Associate Director, Global Regulatory Affairs
Job Type: Permanent
Location: San Francisco
Senior Manager / Associate Director, Global Regulatory Affairs
Remote Based – East or West Coast US
An Associate Director of Global Regulatory Affairs opportunity is now available with a rapidly advancing, global biotechnology business who are focused on innovating novel cancer treatment.
You will be working alongside a highly passionate leadership team and industry experts within a remarkable business where you will take primary lead in the preparation and submission of IND/CTA through to NDA/BLA submissions, whilst acting as the key interface with global project teams and health agencies.
We are seeking exceptional candidates at Associate Director or Senior Manager level who are looking to work alongside amazing leadership or take on the next challenge in their career.
· 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.
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.