SENIOR MANAGER, REGULATORY AFFAIRS CMC
The Senior Manager, Regulatory Affairs CMC will provide regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the treatment of sickle cell disease (SCD) and other disorders. Responsibility will focus mainly on CMC regulatory filings, and providing strategic as well as operational management of the project teams in this area. In addition, responsibilities may include support to on-going clinical activities. The candidate will develop regulatory strategies and manage US and ex-US clinical applications and marketing applications, FDA and other regulatory interactions (responses to requests for information), for the product candidates. This will be an individual contributor and will report to Sr. Director, RA CMC.
Essential Duties and Responsibilities:
- Manage internal review / approval process for CMC related submissions and regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs
- Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval
- Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure regulatory agency approvals are obtained
- Responsible for supporting the filing of IND/CTA/NDA/MAA submissions. Support strategy developed 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
- Support the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones
- Contribute to the preparation of regulatory impact assessments for change control management and deviation reports
- Accrue regulatory intelligence on the regions of interest for GBT products and educate the department of RA at large on the evolution of the regulatory landscape
- Bachelor degree in a Chemistry, Life Sciences or equivalent, advanced degree preferred.
- 6-9+years of relevant experience (at least 3 years of Regulator Affairs CMC experience) and has earned a BS or equivalent degree
- Experience providing guidance to team members
- Experience in eCTD format and structure
- Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills
- Strong project management skills.
- Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations 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
- Can prioritize deadlines, projects, and adapt to quickly changing environment
- Can maintain excellent relationships with peers, despite workoad pressure and tight timelines
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
- Values-based leadership
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.