Associate Director/Director, US Advertising/Promotion Regulatory Affairs Vaccines
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!
location: Bridgewater, New Jersey
job type: Contract
salary: $38.25 - 45.01 per hour
work hours: 8 to 4
The Associate Director/Director serves as the regulatory lead on relative Review Committees (RCs). 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 biologics.
- 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 APLB submission.
- Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising 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
- At least five through seven (5-7) 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 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.
skills: FDA, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.