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Associate Director, Global Regulatory Affairs Ad-Promo - Immuno-Oncology

Principia Biopharma, Inc.

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Cambridge, MA
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Job Description

As posted by the hiring company

Job Overview:

Associate Director, Advertising/Promotion Regulatory Affairs Immunology and Oncology

The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs), and on the respective Medical Materials Review Committees (MMRC). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics.

ESSENTIAL FUNCTIONS:

  • Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.

  • Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.

  • Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials

  • Provide a leadership role on the Medical Materials Review Committee (MMRC) for medical-sponsored materials

  • Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.

  • Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.

  • Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.

  • Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.

  • Serve as FDA liaison for matters related to the advertising and promotion of assigned products.

Other Position responsibilities:

  • Work with other RC team members to provide input into improvement of systems and/or processes.

  • Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies, etc.

  • Review current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed

Competencies and Capabilities

  • This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with OPDP/APLB reviewers

  • The individual will require strong verbal and written communication skills; strong interpersonal skills; good listening skills; strong negotiation skills; demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions.

MINIMUM REQUIREMENTS:

Experience:

  • 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 Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.