Senior Manager, Regulatory Affairs Advertising, Promotion And Labeling

Agios Pharmaceuticals Cambridge , MA 02138

Posted 8 months ago

Sr. Manager, Regulatory Affairs Advertising, Promotion and Labeling

Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicine and multiple first-in-class investigational therapies in clinical or preclinical development.

Agios Pharmaceuticals is searching for a Senior Manager, Regulatory Affairs Advertising, Promotion and Labeling to join our growing Regulatory Affairs team. This newly created role will be responsible for reviewing promotional, educational and scientific communications for Agios products to ensure scientific and medical accuracy and compliance with applicable laws and regulations. This person will provide regulatory input on the preparation of new and revised product labeling for marketed and investigational compounds.

Key Responsibilities:

  • Regulatory reviewer for materials under the appropriate review committee (Agios Promotional Review Committee/Agios Medical Review Committee) for assigned products

  • Provides regulatory expertise in the development, review and approval of compliant, external communications directed to healthcare professionals, consumers or patients and background and training materials developed for internal use

  • Work collaboratively with cross functional teams (i.e., Marketing, Medical Affairs, Legal, Market Access) to ensure scientific and medical external communications are non-promotional and compliant with applicable regulations and corporate policies

  • Support the compilation and submission of materials to Regulatory Authorities (e.g., OPDP) as applicable

  • Collaborates with all stakeholders to create, review, and modify labeling documents, including prescribing information and patient labeling, with attention to competitive positioning

  • Serves as the expert for the regulatory history of Agios labeling and promotional communications and for the analysis of competitor labeling in the relevant therapeutic areas

  • Create, revise and maintain Company Core Data Sheets (CCDS) and Target Label Profiles for Agios products

  • Lead and/or provide support with development and maintenance of regional labeling that aligns with the CCDS and meets the requirements of health authorities

  • Track data sources supporting labeling claims, history of labeling negotiations and changes, and reasons for differences in local labeling

Requirements:

  • BS/BA degree (science or related discipline preferred); graduate degree desirable

  • Minimum of 5 years of professional experience in pharmaceutical/biotechnology industry with promotional material and labeling review experience

  • Demonstrated knowledge of FDA, EMA and ICH guidelines and regulations, with specific expertise in advertising and promotion guidance, labeling guidance and enforcement trends

  • Excellent organizational and communication skills, both written and verbal

  • Ability to work independently as well as part of a team environment

  • Positive attitude, energetic and proactive

  • Proven ability to manage multiple projects, identify and resolve regulatory issues

  • Strong interpersonal skills and the ability to work with others

Agios Competencies

  • Drives and Delivers: Executes and Operates to a High Standard

  • Connect and Relate: Collaborates and Talks Straight

  • Build and Transform: Supports a Learning Environment and Builds Networks

  • Lead from Every Chair: Challenges Self and Others and Drives Clarity


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