Hybrid Position in Los Angeles or San Diego
The Regulatory Consultant will be responsible for:
- Offer CMC Consulting services to multiple clients. ·
- Take proactive measures to oversee the CMC aspects of one or more client programs, including the preparation and submission of CMC documents, such as clinical trial applications.
- Create and evaluate CMC content to ensure its completeness, quality, and alignment with relevant requirements.
- Stay informed about the latest regulatory CMC requirements and apply this knowledge to the projects at hand, offering regulatory guidance to Quality, Manufacturing, Process Development, and other relevant functional groups and stakeholders.
- Lead projects involving cross-functional teams and serve as the main point of contact for regulatory CMC matters in assigned projects.
- Contribute to the development, planning, and execution of regulatory strategies, regulatory risk management, and contingency plans, providing expert recommendations in your area of expertise.
- Conduct regulatory assessments and offer guidance on product compliance issues, including change controls, deviations, and GMP investigations throughout the development process.
- Assist in engaging with the FDA and other global regulatory authorities regarding assigned projects to ensure the swift acceptance, review, and approval of submissions containing CMC information.
The Regulatory Consultant should have the following qualifications:
- Proficiency in the life sciences field.
- Prior experience in regulatory affairs or related roles within drug or biologics development.
- Track record as a regulatory contributor for international original IND, NDA, BLA, MAA filings, either in the United States or Europe.
- While not mandatory, experience in the realm of Cell and Gene therapy is desirable.