Director, Commercial Regulatory Affairs and Labeling

Location
San Francisco, CA, United States
Posted
Jan 12, 2021
Ref
987
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
DIRECTOR, COMMERCIAL REGULATORY AFFAIRS AND LABELING

Position Summary:

The Director, Commercial Regulatory Affairs and Labeling is responsible for leading the development and implementation of labeling strategies for GBT products, including development of a target product label during drug development and post-approval life-cycle management. In addition, this position will assist the Senior Director, Commercial Regulatory Affairs with review of promotional materials. Accountable for developing strategies and timelines, and leading internal team discussions to support preparation of labeling and promotional materials for regulatory submissions. This role will be an individual contributor role; however, the position will work closely with other functional areas such as Research, Development, Technical Operations, Program Management, Legal, Medical Affairs, and Commercial. The Director, Commercial Regulatory Affairs and Labeling reports to the Senior Director, Commercial Regulatory Affairs.

Essential Duties and Responsibilities:

  • Develops and implements labeling strategies, including risk assessments, based on understanding of available data on GBT drug products, regulatory precedence and regional regulatory requirements
  • Manages the preparation and revision of company core data sheets and regional labeling
  • Responsible for the development and implementation of regulatory labeling processes, as necessary
  • Authors commercial regulatory submissions and works closely with Regulatory Operations to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP)
  • Assist in the review of commercial labeling and advertising/promotional materials, based on domestic and international regulatory requirements


Qualifications:

  • 10-14+ years of pharmaceutical industry or equivalent experience and has earned a BS or equivalent degree; MS, MBA or equivalent may be desirable. Minimum of 8 years in Regulatory Affairs; 4+ years of experience leading teams and/or managing people (i.e. employees, contractors) required for leadership positions
  • 4+ years of labeling experience a must
  • In-depth knowledge of the bio/pharma industry
  • Detailed knowledge of global regulatory environment and its impact on product labeling
  • Experience and thorough understanding of the preparation of product labeling from both strategic and operational perspectives
  • Technical knowledge of US FDA regulations as they pertain to product labeling
  • Preferred, but not required: Experience in review of US promotional labeling
  • Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills
  • Exceptional cross-functional team leadership skills
  • Ability to work in close collaboration with others
  • Strong organizational and planning skills, as well as strong attention to detail
  • Accountable for results and goal attainment
  • Ability to work independently with limited supervision, adapt to change and manage multiple tasks
  • Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting
  • Strong computer skills in Word and Adobe Acrobat and working knowledge of electronic publishing/file management. Experience with Veeva Vault PromoMats preferred


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.