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Director Regulatory Affairs
A well known biopharmaceutical company
Great career evolution potential
About Our Client
Recruiting for a biopharmaceutical company based in British Colombia.
- Lead the planning, preparation and delivery of regulatory submissions throughout the product's life cycle
- Ensures appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications and compounds for US Investigational New Drug (IND) applications, Canadian and/or EU Clinical Trial Applications (CTAs), and other jurisdictions as applicable.
- Main contact with US Food and Drug Administration and Health Canada
- Determines and supports emerging department and local business needs in relation to Global Regulatory Affairs.
- Develops regulatory strategic plans in conjunction with project teams and assists in the design of nonclinical and clinical programs required for regulatory approval.
- Responsible for filing of IND, CTA, and other required regulatory submissions.
- Collaborate with other departments to advise of changes in regulatory guidance which may impact the business
- Contribute to the preparation of new regulatory guidance, and communicate the impact of new regulatory requirements or changes in legislation across the organization
The Successful Applicant
- A degree in pharmaceutical, science or a related field.
- At least 8 years' experience in Regulatory Affairs.
- Experience in orphan drug development and/or rare disease indications desirable.
- Exceptional ability to manage the execution of multiple projects with high attention to detail.
What's on Offer
Comptetive salary and benefits