Associate Director, Global Regulatory Affairs Advertising/Promo
Company: Principia Biopharma Inc.
Posted on: June 13, 2021
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.
Provide regulatory leadership and guidance to Commercial teams
during the development, review and approval of product labeling and
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
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
Review content and format of documents, assuring compliance with
corporate policies, federal regulations and guidelines, and product
Work collaboratively with medical and scientific personnel on
the development and review of materials related to advertising and
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.
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.
Strong verbal and written communication skills.
Strong interpersonal skills.
Good listening skills.
Strong negotiation skills.
Demonstrated customer focus.
- Demonstrated ability to facilitate appropriate team
- 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.
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.
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
Keywords: Principia Biopharma Inc., Trenton , Associate Director, Global Regulatory Affairs Advertising/Promo, Other , Bridgewater, New Jersey
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