Associate Director/Director, Global Regulatory Lead (R&D)

Job Description:

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary
We are seeking a talented and motivated Global Regulatory Lead (GRL) to join our growing Development organization at the Associate Director/Director level. As a key member of the core product development team, you will have the opportunity to provide strategic directions 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).
• 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.

Minimum Qualifications

• A bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science.
• Prior regulatory experience with a demonstrated track record of significant accomplishments. Associate Director (12+ Years of relevant experience with a bachelor's degree or 10+ Years of relevant experience with an advanced degree) or Director (15+ Years of relevant experience with a bachelor's degree or 12+ Years of relevant experience with an advanced 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 Qualifications

• 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

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

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