Global Regulatory Lead, Immuno-Oncology

Company: CRISPR Therapeutics
Location: Cambridge
Posted on: June 19, 2022

Job Description:

Company OverviewCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.Job SummaryWe are seeking a talented and motivated Global Regulatory Lead (GRL) to join our growing Research and Development organization at the Associate Director level.Reporting into the Executive Director of Regulatory Affairs, you will be a key member of the assigned oncology core development team(s), working closely with cross-functional teams.As a key member of the core product development team, you will have the opportunity to provide strategic direction to ensure successful product development and approval in alignment with company objectives.In advancing several product candidates into clinical stage, CRISPR Therapeutics will offer the right individuals the opportunity to devise and implement creative global regulatory development strategies to bring novel products to patients as quickly, robustly and efficiently as possible, and to shape the regulatory framework in which we operate.The position provides an excellent opportunity to apply current knowledge and gain experience in the fast growing and advancing field of gene and cellular therapies.As the company grows, you will have the opportunity to contribute to building the organization and further advance your leadership position.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).
• Oversees all submission activities and regulatory writing for regulatory documentation including but not limit to meeting briefing packages, requests for special designations, INDs, BLA/MAAs
• 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.Minimum Qualifications
  • A bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science is required. An advanced degree (MS/MBA, PhD or MD) is preferred.
  • Minimum of 7 years of experience in regulatory affairs strategy roles within the biotech or pharmaceutical industry, with a demonstrated track record of significant accomplishments.
  • 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, Japan).
  • Experience interfacing with regulatory agencies and proven skill at developing, communicating and implementing successful global regulatory strategies.'
  • Experience leading Agency meetings (face to face or teleconference) at key program milestones
  • Experience leading original IND submissions and other key submissions (eg orphan designation, BTD/RMAT applications, PIP/PSP submissions)Preferred Qualifications
    • 10+ years of direct experience leading regulatory affairs strategy, collaborating with clinical leads, interfacing with health authorities, and have lead multiple successful filings
    • Current experience developing novel global oncology/rare disease product regulatory strategies including submissions and approvals of 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.CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Keywords: CRISPR Therapeutics, Cambridge , Global Regulatory Lead, Immuno-Oncology, Healthcare , Cambridge, Massachusetts