Associate Director, Global Regulatory Affairs Ad-Promo (Immuno-Oncology)
Sanofi
12 hours ago
Remote friendly (Morristown, NJ)
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 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 the development and review of advertising and 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 provide input into improvement of systems and/or processes.
- Provide insight into changes in the regulatory environment (e.g., FDA enforcement letters, meetings, guidance documents, policies).
- Review current policies/practices and guidelines from Federal regulatory agencies and update management as needed.
- Represent Regulatory Affairs as part of cross-functional RC teams and for verbal/written communications with OPDP/APLB reviewers.
Qualifications:
- Bachelor’s degree (required) in Life Sciences or other relevant discipline from an accredited four-year college/university.
- 5+ years of experience in pharmaceutical or medical device Regulatory Affairs; 3+ years in advertising & promotion.
- Leadership, mentoring and/or training experience within regulatory or ad/promo (preferred).
Required/Preferred Skills:
- Extensive knowledge of complex medical and scientific subject matter, including statistical data.
- Ability to build networks and obtain cooperation without authority via cross-functional groups (medical, legal, regulatory, etc.).
- Ability to generate innovative solutions.
- Strong verbal and written communication, interpersonal skills, listening skills, negotiation skills, customer focus, and facilitation of appropriate team decisions.
- Ability to establish priorities and timelines, self-manage workload, and multitask effectively.
- Ability to represent information and data accurately and deal honestly/forthrightly.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and 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 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 the development and review of advertising and 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 provide input into improvement of systems and/or processes.
- Provide insight into changes in the regulatory environment (e.g., FDA enforcement letters, meetings, guidance documents, policies).
- Review current policies/practices and guidelines from Federal regulatory agencies and update management as needed.
- Represent Regulatory Affairs as part of cross-functional RC teams and for verbal/written communications with OPDP/APLB reviewers.
Qualifications:
- Bachelor’s degree (required) in Life Sciences or other relevant discipline from an accredited four-year college/university.
- 5+ years of experience in pharmaceutical or medical device Regulatory Affairs; 3+ years in advertising & promotion.
- Leadership, mentoring and/or training experience within regulatory or ad/promo (preferred).
Required/Preferred Skills:
- Extensive knowledge of complex medical and scientific subject matter, including statistical data.
- Ability to build networks and obtain cooperation without authority via cross-functional groups (medical, legal, regulatory, etc.).
- Ability to generate innovative solutions.
- Strong verbal and written communication, interpersonal skills, listening skills, negotiation skills, customer focus, and facilitation of appropriate team decisions.
- Ability to establish priorities and timelines, self-manage workload, and multitask effectively.
- Ability to represent information and data accurately and deal honestly/forthrightly.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.