Job Title: Senior Director/Director of Regulatory
Location: Remote
Pay: $150,000 - $225,000 (dependent on experience)
Summary:
As a Senior Director/Director of Regulatory Affairs, you are responsible for the provision of high-quality regulatory technical advice and development strategies for clients across a wide range of therapeutic indications and will provide regulatory strategy and leadership for all North America and/or International (inc. European) regulatory submissions. You will lead and support teams and efforts around major filing activities and Health Authority interactions, and will provide regulatory support to other departments, project teams, and committees. In this leadership role, you will support the further development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.
About You:
- You have 12+ years or more relevant regulatory affairs experience.
- You possess a comprehensive understanding of financial management.
- You have expertise in all aspects of the drug development process inclusive of regulatory milestones and clinical trials methodology, including a working knowledge of protocols and indications being studied.
- You have specialized knowledge of regulatory activities including but not limited to submissions to regulatory authorities, including INDs/CTAs and amendments, ODDs, and PIPs.
- You can understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
- You are experienced in pharmaceutical product development and marketing authorizations (MAA/CTAs/INDS/NDA and or BLA/sBLA) experience in filings in an eCTD format.
- You are eager to develop, coach, and mentor regulatory team members, ensuring the sharing of best practices across the team.