Kelly Science & Clinical is seeking a Director of Global Regulatory Affairs for a direct opportunity with our clients, a clinical-stage biotechnology company in the San Francisco Bay area focused on oligonucleotide therapeutics for infectious diseases. 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.
Workplace: Onsite in the San Francisco Bay Area
Position Title: Director of Global Regulatory Affairs
Salary: $190,000-230,000/year
Position Overview
Embrace a leadership role that significantly impacts the trajectory of groundbreaking therapeutics. As the Global Regulatory Affairs Director, you will steer our global regulatory strategies to usher our promising HBV small-molecule drug to market. This role is tailor-made for a regulatory connoisseur adept at traversing complex international regulatory frameworks and forging meaningful relationships with regulatory bodies worldwide.
Key Responsibilities
- Strategic Leadership: Architect and champion comprehensive global regulatory strategies to facilitate expedited drug approvals.
- Regulatory Excellence: Spearhead the preparation, submission, and ongoing management of regulatory documents, maintaining dynamic correspondence with key entities such as the FDA and EMA.
- Compliance Guardianship: Safeguard adherence to all pertinent regulations and guidelines throughout the drug development continuum.
- Cross-Functional Advocacy: Provide thought leadership and guidance on regulatory requisites to cross-disciplinary teams, spanning clinical, manufacturing, and marketing domains.
- Regulatory Trends Analysis: Vigilantly track changes within the regulatory environment, evaluating their ramifications on current and prospective drug development endeavors.
- Focal Contact: Serve as the principal liaison with global regulatory authorities, cultivating productive engagements.
- Risk Management: Strategize and implement risk mitigation frameworks to ensure punctual submissions and approvals, minimizing regulatory hurdles and enhancing developmental efficacy.
- Industry Engagement: Engage with thought leaders by participating in select industry meetings and conferences, with up to 10% travel expected.
Qualifications
- Educational Background: BS/MS/PhD in Life Sciences, Pharmacology, Pharmacy, or a closely related field.
- Experience: A minimum of 10 years of expertise in U.S. regulatory affairs within the pharmaceutical sector is essential; global exposure is advantageous.
- Track Record: Demonstrable success in architecting and executing regulatory strategies, specifically for small-molecule drugs.
- Regulatory Expertise: Extensive experience interfacing with the FDA, including NDA filings, and familiarity with infectious disease therapeutic areas is highly desirable.
- Communication Excellence: Superior communication and interpersonal abilities, capable of adept negotiation with regulatory authorities.
Join us to be at the forefront of transformational change in the biopharmaceutical arena, driving innovation and delivering life-changing therapies