Job Title: Regulatory Affairs Project Manager
Location: Foster City, CA (Hybrid)
Employment Type: Contract
Compensation: $60/hr - $75/hr
Job Summary:
We are seeking an experienced Regulatory Affairs Project Manager to join our team within the pharmaceutical industry. The ideal candidate will have expertise in regulatory strategy, drug development, and product registration processes, with a strong focus on biologics, including monoclonal antibodies, gene therapies, vaccines, and biosimilars. This role requires project management expertise, ensuring timely regulatory submissions and compliance with global health authority requirements.
Key Responsibilities:
Develop, implement, and manage regulatory strategies for biologics products, ensuring compliance with FDA, EMA, and ICH regulations.
Provide regulatory guidance on IND, BLA, and CTA submissions.
Oversee the preparation, compilation, and submission of regulatory dossiers, including INDs, BLAs, MAAs, and global filings.
Coordinate with internal teams (clinical, CMC, quality, and manufacturing) to support regulatory submissions and compliance.
Stay updated with evolving global regulatory requirements for biologics across key markets (US, EU, Japan, etc.).
Ensure product compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Regulatory Practices (GRP).
Maintain communication with health authorities and respond to inquiries in a timely manner.
Manage regulatory submission tools and project management software to track regulatory activities.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s or PhD preferred).
Minimum of 5 years of regulatory affairs experience in the pharmaceutical industry, with a strong focus on biologics.
Proven experience managing IND, BLA, and international regulatory submissions.
Deep understanding of the biologics development process and global regulatory requirements (FDA, EMA, ICH, etc.).
Experience in preclinical and clinical regulatory activities, including CMC and post-market submissions.
Strong project management skills, with the ability to handle multiple projects simultaneously.
Proficiency in regulatory submission tools and project management software.
Experience managing biologic product lifecycle, including commercialization.
This is an exciting opportunity for a regulatory expert to lead strategic regulatory initiatives in a dynamic and fast-paced environment.
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