Beam Therapeutics
Specialist, Regulatory Affairs
Beam Therapeutics, Cambridge, Massachusetts, us, 02140
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.
Compile 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 development of 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.
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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.
Compile 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 development of 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.
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