Job Description

Kelly® Science & Clinical is seeking a Director of Regulatory Affairs for a fulltime, Direct Hire role with a pharmaceutical client based in San Fran 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

Location: San Francisco Bay Area (Hybrid)

Schedule: M-F 8AM - 5PM

Job Title: Global Regulatory Affairs Director

Position Overview: The Global Regulatory Affairs Director will play a pivotal role in leading and managing our global regulatory strategy to ensure the successful approval and commercialization of our promising HBV small molecule drug. This position requires a seasoned regulatory expert who can navigate complex international regulations and manage relationships with regulatory authorities worldwide.

Key Responsibilities:

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

Qualifications:

• BS/MS/PhD in Life Sciences, Pharmacology, Pharmacy, or a related degree
• Minimum of 10 years of experience in U.S. regulatory affairs, specifically within the pharmaceutical industry. Global experience is a plus.
• Proven track record of successfully leading regulatory strategy and submissions for small molecule drugs.
• Experience working with the FDA and filing NDAs.
• In-depth knowledge infectious disease related therapeutic areas is a plus.
• Excellent communication and interpersonal skills, with the ability to engage and negotiate with regulatory authorities.

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