Manager, Regulatory Affairs

MANAGER, REGULATORY AFFAIRS

Position Summary:

As Manager, Regulatory Affairs, you will actively contribute to the development of GBT's investigational product by serving as the regulatory representative on global clinical trials .Your responsibilities will include coordinating clinical regulatory submissions such as IND/CTA, supporting new and ongoing clinical trials, and providing guidance to project teams regarding regulatory submission strategy and requirements that are consistent with current regulations, guidelines and industry standard.

Come join us and be part of an exciting and highly collaborative team in this unique time of growth and opportunities at GBT!

Essential Duties and Responsibilities:

• Represent Regulatory on the clinical project team for a global clinical trial.
• Support the preparation and/or review of clinical filings in the US and ex-US, including but limited to CTAs.
• Perform regulatory review of clinical study documents (e.g., ICFs, and study labels) for adherence to regulations, guidelines, commitments and strategies.
• Coordinate written responses to information requests from regulatory authorities.
• Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect GBT projects.
• Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
• Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel.
• Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
• Assure compliance with project team timelines and milestones

Qualifications:

• Bachelor's degree, preferably in a science or similar discipline.
• 3 to 5 years of experience in the pharmaceutical/biotechnology industry including at least 3 years in Regulatory Affairs.
• Strong knowledge of FDA/ICH regulations and guidelines.
• Excellent organizational, interpersonal, and communication skills with the ability to build relationships at all levels of the organization.
• Ability to work independently on multiple projects with tight timelines and minimal supervision
• Experience working in cross-functional, global, virtual.
• Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions.
• Experience in eCTD format and structure.
• General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Excitement about the vision and mission of GBT
• Integrity
• Values-based leadership
• Flexibility

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.