Director, Regulatory Affairs
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Director, Regulatory Affairs.
Major tasks and responsibilities include:
- Develops CMC regulatory submission strategies, reviews content, and maintains submission timelines to meet business objectives.
- Proactively identifies regulatory issues and provides solutions to keep assigned programs on time and of high quality.
- Leads efforts for coordinating CMC and overall content for original INDs, and IND amendments for inclusion in Clinical Trial Applications and NDAs.
- Works with the CMC team on plans for NDA/MAA submissions and leads preparation.
- Participates in multidisciplinary efforts to prepare updates for regulatory documents including Investigator Brochures, Annual Reports, IND, CTA and NDA submissions and background documents for Regulatory Authority meetings.
- Works with multiple functional groups to prepare applications and respond to Health Authority queries in a timely fashion.
- Establishes, manages, and maintains a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interprets and communicates relevant issues to colleagues.
- Ensures communication and alignment on regulatory strategies through partnership and communication with internal key stakeholders.
- Assures compliance with regulatory standards and guidance documents.
- Prepares, submits, tracks, indexes, and archives electronic submissions.
- Ensures that IND amendments, post-approval changes, annual reports, and CMC-related changes are reported to authorities in accordance with regulatory requirements.
- Conducts risk assessments of global CMC regulatory issues.
We seek candidates with the following qualifications:
- Performs other duties as assigned.
- An advanced degree is required. A PhD is preferred.
- Must have experience with NDA preparation and submission.
- 10+ years of drug development and regulatory affairs experience in the Biotech/Pharmaceutical industry is required.
- Requires experience in drug development and approval processes (INDs, NDAs, MAAs) across all phases of development.
- Must have demonstrated knowledge of regulatory aspects of small molecule Chemistry, Manufacturing and Controls.
- Experience in Quality Assurance is a plus.
- Experience with labeling requirements is a plus.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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