The Director, CMC Regulatory Affairs will provide leadership, and drive to successful completion on all CMC regulatory activities for GBT compounds, including compounds for the treatment of hematologic disorders, particularly Voxelotor for the treatment of sickle cell disease.
Responsibility includes CMC regulatory filings and providing strategic as well as operational leadership on the project teams. The candidate will develop regulatory strategies, manage/oversee IND/CTA submissions and forthcoming NDA/MAA planning activities, including FDA CMC Pre-NDA meeting activities, EMA CMC Scientific Advice and PRIME meeting activities and other regulatory agency interactions.
Essential Duties and Responsibilities:
Manage direct reports and CMC RA consultants that may be contributing to projects
Provide interpretation of regulatory authorities’ feedback, policies and guidelines to GBT personnel and lead Regulatory Affairs CMC-related interactions. Serve as a liaison between GBT and regulatory authorities. Represent GBT before regulatory authorities on designated programs
Develop regulatory strategic plans in conjunction with project teams, and provide input specifically for dosage forms to be used in the design of nonclinical and clinical study programs required for regulatory approval
Work with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained
Responsible for CMC components of IND/CTA/NDA/MAA submissions. Set strategy for submissions of product registration documents to health authorities worldwide. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions
Effectively plan, organize, and conduct in close collaboration with leads from other functional areas formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Assure compliance with project team timelines and milestones
Provide organizational support and be prepared to manage personnel as company grows its product development pipeline
Bachelor’s degree in a Life Sciences discipline or equivalent, advanced degree preferred
At least 12 to 15 years of biopharmaceutical experience, of which at least 10 years of hands-on Regulatory Affairs and successful IND and NDA/MAA submission experience
Experience with both small molecules and biologics.
Experience with pediatric drug dosage form development is a plus
Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills
Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations is a plus
Demonstrated excellence in regulatory liaison/strategy.
Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams
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
Values-based leadership consistent with GBT's Core Values
Excitement about the vision and mission of GBT
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 race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Internal Number: 284
About Global Blood Therapeutics
GBT is a clinical-stage biopharmaceutical company determined to discover, develop and deliver innovative treatments that provide hope to underserved patient communities. GBT is developing its lead product candidate, voxelotor, as an oral, once-daily therapy for sickle cell disease.