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Specialist I/II, Regulatory Affairs

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

130000.00 - 160000.00 USD / Year

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Job Description:

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

Job Responsibility:

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

Requirements:

Minimum BA/BS degree in a scientific/engineering discipline
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
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

Nice to have:

Cell and gene experience preferred
Diverse experience including drugs, biologics, devices and international filings preferred

Additional Information:

Job Posted:
March 22, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

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