Company Overview:
Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
The Regulatory Specialist will participate in the preparation of documentation packages for global regulatory submissions.
Responsibilities:
- 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
- Develop and maintain 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:
- Minimum BA/BS degree in a scientific/engineering discipline
- Cell and gene experience preferred
- 6+ years’ experience in the biotech industry
- 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
- Ability to exercise sound judgment to determine appropriate action of tasks
