Senior Director, Commercial Regulatory (Advertising and Promotion)

Location
Brisbane, California, United States
Posted
Sep 21, 2020
Ref
896002723
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a pa rt of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on mak ing things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference . If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.

SUMMARY:We are seeking a motivated and ambitious individual to lead commercial regulatory activities to enable the business to meet its commercial needs in a compliant manner, with initial focus on supporting MyoKardia's first commercial product launch.

Specific Responsibilities for Position:

The Senior Director will be an instrumental role in preparing MyoKardia's first commercial product launch. In addition to being a key member of the launch team, she/he will serve as the Promotional Review Committee Chair. This role will report to the Head of Regulatory Affairs (Vice President).

Key Responsibilities:
  • Responsible for providing commercial regulatory leadership for assigned programs.
  • Conduct review and approval of promotional materials.
  • Serve as regulatory liaison to FDA/CDER/OPDP.
  • Represent Commercial Regulatory (Advertising and Promotion) at labeling meetings and provide strategic regulatory guidance, as appropriate.
  • Provide regulatory guidance on new concepts and new campaigns.
  • Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely advice to the team.
  • Build and lead a Commercial regulatory team, scaling with the needs of current and future commercialization activities
  • Recognized as an expert resource for regulatory advice across departments.
  • May contribute to process improvements relevant to commercial regulatory activities, including the Promotional Review Committee.

Education/Experience:
  • Bachelors or advanced degree in a scientific discipline, with a minimum of 12 years of regulatory experience in the biopharmaceutical industry; minimum 6 years experience in the regulatory review of promotional materials for prescription drug and/or biologic products.
  • Experience leading a Regulatory Labeling function desired

Knowledge/Skills:
  • Direct experience with FDA's Office of Prescription Drug Promotion (OPDP) submissions and strategies.
  • Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is required.
  • Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
  • Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions.
  • Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others.
  • Some travel required. Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.