Director Regulatory Affairs (Ad/Promo)
Company: Otsuka Pharmaceutical
Posted on: August 6, 2022
Job DescriptionDirects or assists staff member(s) and
independently reviews and approves content and required of
promotional labeling materials for prescription drug and medical
device products. Ensures that promotional labeling and training
material meet regulatory and company requirements. The candidate
must demonstrate a high level of understanding of promotion
compliance and labeling. May be assigned additional
responsibilities as deemed necessary.Job Description
- Supervises direct and/or indirect report(s) or acts to ensure
all promotional and labeling materials are in compliance with
relevant laws and regulations. Analyses and interprets new
regulations and Guidance document as well as monitors and
determines the impact of Office of Prescription Drug Promotion
(OPDP) correspondence and enforcement actions.
- Supervises direct and/or indirect report(s) or participates in
the development, maintenance, and approval of promotional labeling
components, and provides strategic advice in labeling meetings for
development of promotional messages
- Supervises direct and/or indirect report(s) or reviews
promotional and commercial communication materials to ensure that
the information conveyed is consistent with the product labeling
and is suitable for their intended audience and use.
- Responsible for final review and approval of promotional and
sales training materials, and corporate communications, and
corporate communications as needed, as appropriate.
- Ensures product promotional materials are submitted to OPDP on
Form FDA 2253 in a timely manner as per regulations, and that
materials are archived as per company policy.
- Monitors and informs others of changes in US labeling and
promotional regulations as well as corporate policies and
procedures, as appropriate. Utilizes these changes in developing
and modifying company procedures.
- Manages contracts for contractors and consultants.
- Attends cross functional teams: Global Regulatory Team (GRT),
Global Labeling Team (GLT).
- Provides training to OAPI/OPDC employees and affiliates on
regulations for promotion compliance, as appropriate.
- Acts as liaison between the company and OPDP. Arranges and
leads meetings with OPDP as appropriate.QualificationsKnowledge/
Experience and Skills:Required:
- Solid understanding of US regulatory requirements
- Broad knowledge of clinical medicine and clinical
- Excellent understanding of medical concepts and
- Solid understanding of the structure and function of the
- Fundamental understanding of the pharmaceutical industry drug
- Able to work across multifunctional groups
- Strong written and oral communication skills
- Strong computer skills including experience with MS Office:
Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams,
and Adobe Acrobat
- The ideal candidate should be action oriented, customer
focused, and have the ability to manage workloads, set priorities,
demonstrate managerial courage to build effective teams. In
addition, the candidate should be capable of dealing with
ambiguity, be creative, be comfortable working with multifunctional
teams, and show strong business acumen.Educational
- Bachelor's Degree and 6+ years of experience in promotional
pharmaceutical compliance and product labelingPreferred:
- MD, MS, PhD, or PharmD and 3+ years of experience in
promotional compliance and product labeling in the pharmaceutical
Keywords: Otsuka Pharmaceutical, Trenton , Director Regulatory Affairs (Ad/Promo), Executive , Princeton, New Jersey
Didn't find what you're looking for? Search again!