Global Regulatory Lead, Hemoglobinopathies
Posted on Apr 5, 2021 by CRISPR Therapeutics AG
We are seeking a talented and motivated Global Regulatory Lead (GRL) to join our growing Research and Development organization at the Associate Director/Director level.
Reporting into the Executive Director of Regulatory Affairs, you will be a key member of the assigned hemoglobinopathies core development team(s), working closely with cross-functional teams and partners.
As a key member of the core product development team, you will 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.
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 and routine submissions.
Ensure consistency of evidence-based global product communication (eg 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.
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 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 (ie EU, US, Japan).
Experience interfacing with regulatory agencies and proven skill at developing, communicating and implementing successful global regulatory strategies.
Candidate must have experience with late-stage development programs and submission of BLAs/MAAs.
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.