The Senior Manager of Regulatory Affairs will provide leadership on global clinical regulatory activities for GBT compounds for the treatment of sickle cell disease (SCD). Responsibility will mainly focus on clinical regulatory filings and providing strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and NDA submissions activities, as well as international submission activities, for the product candidates.
Roles and Deliverables
• Provide interpretation of regulatory authorities’ feedback, policies and guidelines to GBT personnel.
• Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of clinical submissions 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 filing of IND/CTA and contribute and/or lead NDA/MAA submission activities. Interacts 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. 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.
• Five-8 years of biopharmaceutical experience, of which at least 5 years including hands-on Regulatory Affairs and successful IND and NDA/MAA submission experience.
• 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 a plus.
Essential Skills & Abilities
• 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
Drive, desire, motivation
• Ability to thrive in a fast-paced, entrepreneurial environment with high performing colleagues
Fit with GBT culture
• Ability to build strong relationships with co-workers of various backgrounds and expertise