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Job Description

Company Overview

At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases. We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other serious diseases with unmet medical need.

Our multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting -thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

Job Summary

We are seeking a talented and motivated Global Regulatory Lead (GRL) to join our growing Research and Development organization at the Director/Senior Director/Executive Director level.

Reporting into the Head of Regulatory Affairs, you will be a key member of the assigned 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).

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 10 years of experience in 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.
  • Prior management experience. Proven ability to build and lead effective, well integrated, matrixed, collaborative teams and empower team members.

Preferred Qualifications

  • Current experience developing novel global hematology/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: -us/privacy-policy

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Associated topics: business, care, donor, government, lead generation, major gift, market, policies, presale, social media

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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