Manager, CMC Regulatory Affairs

Location
San Francisco, CA, United States
Posted
Nov 02, 2018
Ref
325
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
MANAGER, CMC REGULATORY AFFAIRS

Position Summary:

The Manager, CMC Regulatory Affairs, will work closely with cross-functional CMC teams and provide regulatory guidance on global CMC regulatory activities for Global Blood Therapeutics (GBT) compounds for the treatment of sickle cell disease (SCD) and other disorders.

Essential Duties and Responsibilities:
  • Support and prepare CMC regulatory submissions: IND/CTA, NDA and MAA
  • Provide strategic, as well as, operational management to the project teams in this area
  • Develop regulatory strategies and manage US/ex-US clinical applications and regulatory responses to requests for information for the product candidates
  • Support on-going clinical trial activities
  • Manage internal review / approval process for CMC related submissions and responses to regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate
  • 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
  • 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
  • Evaluate proposed CMC changes for global regulatory impact to ongoing and existing filings, and provide a regulatory assessment and a submission strategy for optimal implementation of changes
  • 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
  • Provide organizational support as company grows its product development pipeline

Qualifications:
  • Bachelor's degree in a life sciences, chemistry, or related discipline, advanced degree preferred
  • 3 to 5 years of biopharmaceutical experience, of which at least 3 years including hands-on Regulatory Affairs and successful IND and NDA/MAA submission experience
  • Post approval regulatory experience is a plus
  • Experience and knowledge in analytical chemistry is preferred, but not required
  • 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
  • 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 contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


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.