Director of Regulatory Affairs, Clinical Research

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Senior Recruiter at Kelly Science & Clinical | Clinical Research | Government Locum Tenens

Kelly Science & Clinical is seeking a Director of Regulatory Affairs for a full-time, direct-hire role with a pharmaceutical client based in the San Francisco Bay area. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Base Salary Starting at: $190,000

Schedule: M-F 8AM - 5PM

Job Title: Global Regulatory Affairs Director

Position Overview: The Global Regulatory Affairs Director will lead and manage our global regulatory strategy to ensure the successful approval and commercialization of our HBV small molecule drug. This role requires a seasoned regulatory expert capable of navigating complex international regulations and managing relationships with regulatory authorities worldwide.

Key Responsibilities:

1. Develop and implement robust global regulatory strategies
2. Lead the preparation, submission, and maintenance of regulatory filings and correspondence with agencies (e.g., FDA, EMA)
3. Ensure compliance with all relevant regulations and guidelines throughout drug development
4. Provide strategic guidance on regulatory requirements to internal teams, including clinical, manufacturing, and marketing
5. Monitor regulatory landscape changes and assess their impact on ongoing and future activities
6. Act as the primary contact between the company and global regulatory authorities
7. Manage regulatory risks and develop mitigation strategies to ensure timely submissions and approvals
8. Up to 10% travel to industry meetings and conferences

Qualifications:

1. BS/MS/PhD in Life Sciences, Pharmacology, Pharmacy, or related field
2. Minimum of 10 years of experience in U.S. regulatory affairs within the pharmaceutical industry; global experience is a plus
3. Proven success in leading regulatory strategies and submissions for small molecule drugs
4. Experience working with the FDA and filing NDAs
5. In-depth knowledge of infectious disease therapeutic areas is a plus
6. Excellent communication and negotiation skills with regulatory authorities

Seniority level

• Director

Employment type

• Full-time

Job function

• Research, Science, and Management

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