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:
- Provides regulatory expertise and guidance within a collaborative cross-functional team.
- Acts as the direct liaison between the organization and the FDA.
- Advises and oversees the development and implementation of regulatory strategy through non-clinical, clinical, and other processes.
- Supports the preparation of, and participates in (as appropriate), key Health Authority interactions.
- Assures consistent positions on common issues are presented to Health Authorities.
- Drives the development and on time completion of Health Authority background documents and responses to queries from Health Authorities.
- Provides strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs.
- Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs) and orphan drug designations.
- Sustains excellent relationships with regulatory agency personnel.
- Responds to requests for additional data, organizes and manages participation in meetings as well as negotiates directly with regulatory authorities regarding company’s filings.
We seek candidates with the following qualifications:
- Maintains regulatory strategy documentation for assigned projects.
- A Bachelor’s Degree or equivalent is required. An advanced degree is preferred.
- Must have experience with IND submissions and Orphan Drug designations.
- Requires 8+ years of experience in Regulatory Affairs.
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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