Director, Regulatory Affairs CMC (Remote Position)
DIRECTOR, REGULATORY AFFAIRS CMC (Remote Position)
The Director, Regulatory Affairs will provide leadership and 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 strategic and operational oversight of CMC regulatory submissions and 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:
- Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval
- Lead the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones
- Lead 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
- Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs
- Lead 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
- Prepare regulatory impact assessments for change control management and deviation reports
- Ensure compliance with regulatory procedures and work practices; support processes by which regulatory submissions are reviewed, finalized, and signed-off
- Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks
- Train and mentor regulatory personnel on strategic matters related to company and external information
- 9-14+ years of relevant experience and has earned a BS or equivalent degree; MS, MBA or equivalent may be desirable
- 4+ years of experience leading teams and/or managing people (i.e. employees, contractors)
- 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
- 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 workload 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
- 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 age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.