Specialist I/II, Regulatory Affairs

Position Overview:

The Regulatory Specialist will participate in the preparation of documentation packages for global regulatory submissions.

Primary Responsibilities:

• Able to prepare documentation packages for global regulatory submissions (including IND, CTA, Briefing Books, Scientific Advice, etc.) to the FDA and global regulatory agencies.
• Compiles documentation for submissions to FDA and global regulatory agencies.
• Support the development of regulatory strategies, risks and key issues in an evolving regulatory landscape.
• Support the develop regulatory processes and procedures of regulatory submissions.
• Develops and maintains collaborative partnerships with key internal and external stakeholders.
• Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.

Qualifications, Knowledge and Skills:

• Minimum BA/BS degree in a scientific/engineering discipline.
• Cell and gene experience preferred.
• 6+ years’ experience in the biotech industry.
• 8-10+ years’ experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions.
• Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
• Diverse experience including drugs, biologics, devices and international filings preferred.
• Strong experience with CTD format and content regulatory filings.
• Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
• Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.
• Demonstrates independence of ideas and contributes to the development and execution of the group’s activities.
• Exercises sound judgment to determine appropriate action of tasks.