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Director, Regulatory Affairs (Advertising & Promotion)

Cambridge, Massachusetts 02142

Post Date: 03/07/2018 Job ID: 1866 Job Category: Clinical: Regulatory

My client is seeking a creative, resourceful, strategic thinker for an important role that is responsible for overseeing the regulatory assessment of external communications regarding products; develop and review regulatory strategies for promotional materials for marketed and pipeline products; provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs, and serve as a the lead regulatory affairs representative on the oversight committees for our lead compound.

Job  Responsibilities:
  • Provide regulatory oversight of advertising and promotional activities for the Company’ s lead compound
  • Develop and implement strategies for achieving effective and compliant communications for commercially available products and investigational products.
  • Work collaboratively with cross-functional teams (stakeholders include Marketing, Medical Affairs, Legal, Compliance, R&D) from concept through approval, use and sunset to develop and review materials which are compliant with applicable regulations, guidelines, corporate policies and product development objectives.
  • Work collaboratively with cross-functional teams (Medical Science, Medical Affairs, Clinical Operations, Legal, etc) to ensure scientific and medical external communications are non-promotional and compliant with applicable regulations, guidelines corporate polices and product development objectives.
  • Oversee the compilation and submission of materials to Regulatory Authorities (e.g. OPDP) as applicable.
  • Correspond with Regulatory Agencies related to external communications for the Company’ s products.
  • Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
  • Work collaboratively with Compliance to ensure that approved materials are used within the intended guidelines and duration of use.
  • Ensure that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising
  • Participate in training of sales and marketing personnel on promotion, marketing, labeling and advertising regulations.

Qualifications/  Requirements:
  • Bachelor’ s Degree (B.S.) and a minimum of five to seven years related experience in Regulatory Affairs-Advertising and Promotion; minimum of ten years of biotech/pharmaceutical experience in various applicable roles.
  • At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
  • At least three (3) years in a team leadership role with highly effective people management skills
  • Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities.

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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