CRISPR Therapeutics · 1 hour ago
Associate Director, Global Regulatory Lead
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$170K/yr - $195K/yr
10+ years expCRISPR Therapeutics is a leading company in gene editing with a diverse portfolio of product candidates. They are seeking a talented Global Regulatory Lead to provide strategic direction for product development and approval, ensuring alignment with company objectives and regulatory frameworks.
BiopharmaBiotechnologyGeneticsMedical
Responsibilities
Provide strategic vision and innovative scientific and regulatory leadership in defining a comprehensive science-based, solution-oriented global regulatory development strategy for assigned projects to achieve high quality and timely product registration and effective regulatory agencies interactions aligned with stakeholders needs
Pro-actively establish and maintain high-quality working relationships with regulatory agencies as appropriate for assigned therapeutic areas and products. Monitor and assess impact of relevant global regulations and the evolving regulatory, scientific and competitive environment
Represent Global Regulatory Affairs on assigned core product development teams and other relevant teams and/or governance bodies, including external alliances and partnerships. Provide regulatory expertise and guidance to product development teams and other functions of the company as needed, including by applying appropriate competitive decision making
Provide regulatory direction in product development to align medical need with business objectives in the context of available and expected scientific data, and regulatory guidance and precedent
Lead the planning and implementation of global regulatory filings (IND/CTAs, BLAs)
Oversee all submission activities and regulatory writing for regulatory documentation including but not limited to meeting briefing packages, requests for special designations, INDs, BLA/MAAs and routine submissions
Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)
Present regulatory plans, risk assessments and strategies, pertaining to the assigned project(s), including innovative strategic options which communicate the associated risks
Qualification
Required
A bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science
Prior regulatory experience with a demonstrated track record of significant accomplishments:
10+ Years of relevant experience with an advanced degree
12+ Years of relevant experience with a bachelor's degree
Candidates must have a thorough knowledge and understanding of pharmaceutical and/or biological product development and regulatory requirements for product development and approval in more than one key region (i.e. EU, US, New Zealand, or Australia)
Experience interfacing with regulatory agencies and proven skill at developing, communicating and implementing successful global regulatory strategies
Demonstrated ability to communicate and write clearly, concisely, and effectively
Experience driving documents through from start to finish with tight timelines and cross-functional study teams
Strong analytical skills and ability to interpret and present complex data clearly
Independently motivated, and good problem-solving ability
Preferred
An advanced degree (MS/MBA, PhD or MD)
Current experience developing new product regulatory strategies including submissions and approvals from early development through marketing applications
Working knowledge of cellular and gene therapies or biologics development and manufacture, and relevant global regulatory environment
Detailed knowledge of requirements for preparation of key regulatory documents for INDs, CTAs, BLAs and annual reports. Prior preclinical or clinical regulatory foundation
Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
Experience working in a small biotech environment
Detailed knowledge of requirements for preparation of key clinical and regulatory documents for INDs, CTAs, BLAs and annual reports
Benefits
Bonus
Equity
Benefits
Company
CRISPR Therapeutics
CRISPR Therapeutics is focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.
201-500 employees
H1B Sponsorship
CRISPR Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (25)
2023 (16)
2022 (18)
2021 (13)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$407MKey Investors
EcoR1 CapitalBill & Melinda Gates FoundationVersant Ventures
2024-02-13Post Ipo Equity· $280M
2020-12-14Grant
2016-10-19IPO
Leadership Team
Raju Prasad
Chief Financial Officer
Naimish Patel
Chief Medical Officer
Recent News
2025-12-26
2025-12-26
The Motley Fool
2025-12-25
Company data provided by crunchbase