Associate Director, Global Regulatory Affairs Ad-Promo (Immuno-Oncology)
Sanofi
12 hours ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Main Responsibilities
- 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.
- Collaborate with Compliance and Legal to ensure that RC-approved materials are used within intended guidelines.
- Review content and format of documents to assure compliance with corporate policies, federal regulations and guidelines, and product development objectives.
- Collaborate with medical and scientific personnel on development and review of advertising/promotion materials.
- 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 improve systems and/or processes.
- Provide updates on changes in the regulatory environment (e.g., FDA enforcement letters, meetings, guidance documents, policies).
- Review current federal regulatory policies/practices and update management as needed.
- Represent Regulatory Affairs on cross-functional RC teams and in verbal/written communications with OPDP/APLB reviewers.
Qualifications
- Bachelor’s degree (required) in Life Sciences or a relevant discipline.
- 5+ years of Regulatory Affairs experience in pharma or medical devices; 3+ years specifically in advertising & promotion.
- Leadership/mentoring/training experience in regulatory or ad/promo (preferred).
Required/Preferred Skills
- Extensive knowledge of complex medical/scientific subject matter (including statistical data).
- Ability to build networks and obtain cooperation without relying on authority (including cross-functional medical/legal/regulatory groups).
- Ability to generate innovative solutions and try novel approaches.
- Strong verbal/written communication, interpersonal, listening, and negotiation skills; customer focus; ability to facilitate appropriate team decisions.
- Ability to set priorities/timelines, self-manage workload, and multitask.
- Honesty and accuracy in representing information and data.
Benefits (explicitly stated)
- At least 14 weeks’ gender-neutral parental leave.
- 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.
- Collaborate with Compliance and Legal to ensure that RC-approved materials are used within intended guidelines.
- Review content and format of documents to assure compliance with corporate policies, federal regulations and guidelines, and product development objectives.
- Collaborate with medical and scientific personnel on development and review of advertising/promotion materials.
- 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 improve systems and/or processes.
- Provide updates on changes in the regulatory environment (e.g., FDA enforcement letters, meetings, guidance documents, policies).
- Review current federal regulatory policies/practices and update management as needed.
- Represent Regulatory Affairs on cross-functional RC teams and in verbal/written communications with OPDP/APLB reviewers.
Qualifications
- Bachelor’s degree (required) in Life Sciences or a relevant discipline.
- 5+ years of Regulatory Affairs experience in pharma or medical devices; 3+ years specifically in advertising & promotion.
- Leadership/mentoring/training experience in regulatory or ad/promo (preferred).
Required/Preferred Skills
- Extensive knowledge of complex medical/scientific subject matter (including statistical data).
- Ability to build networks and obtain cooperation without relying on authority (including cross-functional medical/legal/regulatory groups).
- Ability to generate innovative solutions and try novel approaches.
- Strong verbal/written communication, interpersonal, listening, and negotiation skills; customer focus; ability to facilitate appropriate team decisions.
- Ability to set priorities/timelines, self-manage workload, and multitask.
- Honesty and accuracy in representing information and data.
Benefits (explicitly stated)
- At least 14 weeks’ gender-neutral parental leave.