Director, Regulatory CMC
Beam Therapeutics
$210,000 - $260,000 / year
Need a reasonable accommodation to apply or interview? Contact us.
JobMinglr uses automated technology to recommend jobs based on profile information and job preferences. Match Score does not determine eligibility for a position, prevent a user from viewing or applying to a job, or make hiring decisions on behalf of an employer.
Description
Company Overview:
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and 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 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 Director, Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead regulatory activities to support high quality CMC sections of regulatory documentation.
Responsibilities:
- Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/ex-vivo and in-vivo therapies.
- Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape.
- Act as the regulatory CMC lead and department representative in matrix teams for development programs.
- Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
- Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
- Plan and manage activities for the preparation of high quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings in accordance with program timelines.
- Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes.
- Develop regulatory processes and procedures to support CMC components of regulatory submissions.
- Support the creation and maintenance of CMC submission templates and dossier standards.
- Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
- Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
- 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 CMC regulations and guidance, and provide regulatory advice to CMC and project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.
Qualifications:
- BA/BS degree in a scientific/engineering discipline with 15 + years experience, 10 of which in the biotech industry; Level will be commensurate with experience.
- 9+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) with direct technical writing experience for IND/CTA/MF and BLA/MAA submissions.
- Experience with cell and gene therapy and/or lipid nanoparticles is desirable.
- 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 biologics in the cell therapy space, drugs, 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.
- Onsite requirements: candidates are expected to come onsite 1-3 days per week.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
About this role
Beam Therapeutics is seeking a regulatory leader to guide the CMC strategy and execution for its precision genetic medicine programs, which span ex-vivo and in-vivo therapies built on the company's base editing platform. This role sits at the intersection of regulatory compliance, scientific rigor, and cross-functional collaboration—you would own the CMC sections of regulatory submissions (IND, CTA, BLA, MAA), lead health authority interactions on manufacturing and quality topics, and provide strategic guidance on how evolving regulatory landscapes affect the company's filing approach. The position demands someone who can translate complex technical and regulatory requirements into clear, data-backed arguments while managing the practical details of dossier preparation and GMP inspection readiness.
The ideal candidate brings at least 15 years in the life sciences with 9+ years specifically in regulatory CMC or closely related disciplines like manufacturing, analytical, or quality assurance. You'll need hands-on experience writing IND and BLA submissions, deep familiarity with FDA, EMA, and ICH guidelines, and the ability to apply them creatively to novel modalities. Prior exposure to cell and gene therapy or lipid nanoparticles is valued; experience across multiple therapeutic modalities and international filings strengthens your candidacy. Beyond technical credentials, this role requires strong communication skills, organizational discipline, and the flexibility to pivot as priorities shift in a fast-moving biotech environment.
Based in Cambridge and expected onsite one to three days per week, this full-time position offers a salary range of $210,000 to $320,000, calibrated to your experience and scope.
How this employer is doing
average
- H1B: Sponsors Visas
- Recent Acquisition
- Sponsors Visas
In the news
720,648 Shares in Beam Therapeutics Inc. $BEAM Purchased by Bank of America Corp DE, Americanbankingnews
This role's local market on JobMinglr
Pay for this role
$210,000 to $260,000 per year
That is the employer's posted range, and where you land in it is usually decided in one conversation. Before that conversation, run the numbers: analyze an offer for this role.
Before you apply, worth reading
How JobMinglr reads this job
Every listing here is scored against your profile before you apply: skills overlap, experience level, location and work arrangement, each weighted and explained. You see the score and the reasons, not just a list. How the matching works.