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Associate Director, US Advertising and Promotion, Global Regulatory Affairs

Company: Sanofi EU
Location: Cambridge
Posted on: June 8, 2024

Job Description:

Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs

Location: Cambridge, MA or Bridgewater, NJ

About the job

The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the advertising and promotion of prescription drugs, biologics, and devices.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials.
Develop solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks.
Work directly with Commercial teams from concept through review and approval, up to and including APLB submission.
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.
Must be confident in their analysis and application to impacted materials to ensure compliance with the regulations.
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.

About you

At least five 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.
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.
Bachelor's degree from an accredited four-year college or university (Area of specialization: Life Sciences)
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.

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#LI-SA

#LI-Hybrid

Keywords: Sanofi EU, Cambridge , Associate Director, US Advertising and Promotion, Global Regulatory Affairs, Advertising , Cambridge, Massachusetts

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