Manager Regulatory Commercial
Company: NS Pharma, Inc.
Posted on: May 13, 2022
Support or serve as a regulatory advertising and promotion reviewer
on cross-functional Promotional Review Committee (Legal, Medical,
Regulatory - LMR) and Medical Review Committees (MRCs). Provide
regulatory guidance and strategies on advertising/promotion and
medical materials. Coordinate and manage all LMR and MRC review
committee meetings, as well as, all submissions to OPDP.
Essential Duties and Responsibilities (Include but not limited to
the following. Other duties may be assigned.)
Support or serve as a primary regulatory advertising and promotion
reviewer for assigned products on LMR teams in consultation with
Director Regulatory Affairs, as needed
Assist in all interactions with the FDA Office of Prescription drug
Promotion (OPDP) for assigned company products, responsible for
helping to maintain working relationship and effective
communication with FDA OPDP reviewers with respect to advertising
and promotion matters; may serve as a liaison with OPDP regarding
advertising and promotion for assigned products;
Provide strategic regulatory advice on advertising and promotion
materials and activities for assigned products in accordance with
business goals and objectives, FDA regulations/guidance's, PhRMA
guidelines and company policy in consultation with Director
Regulatory Affairs, as needed;
Provide FDA regulations, guidance, and enforcement trends governing
the non-promotional and promotional communication materials;
monitor U.S. regulatory promotional environment (review regulatory
promotional guidelines, untitled and warning letters to
pharmaceutical companies published by OPDP); Maintain awareness of
competitor activities by monitoring major U.S. Medical meetings
where assigned therapeutic area products are promoted;
Interact with participants of varying levels and experience to
facilitate meetings and steer productive discussions to ensure
regulatory promotional compliance while memorializing MLR Reviewer
Maintain Veeva system and keep-up-to date and ensure
Responsible for coordinating preparation, compilation and
submission (including Form FDA 2253) of promotional materials
Work with Director Regulatory Strategy or designee to ensure that
regulatory strategy will result in commercially viable U.S.
labeling upon which future promotion and advertising will be
Provide input during labeling development and negotiation to
reflect commercialization objectives and messages that impact
promotion and advertising; participate in U.S. labeling
negotiations and FDA meetings as necessary;
Perform other tasks as necessary and/or required to ensure
regulatory compliance while effectively managing business
Knowledge of regulations/guidelines governing development of
pharmaceuticals; experience working with FDA.
Experience in regulatory launch of new product and sub part H
accelerated approval products.
Experience interfacing with FDA.
Must be able to provide creative solutions to problems.
Must be able to work effectively in a multi-cultural, global team
environment as responsibilities include collaboration with internal
and external partners.
Must be flexible, hands-on and willing to take on a variety of
Excellent oral and written communication skills.
Education and/or Experience
BS, MS, PhD or PharmD (strongly preferred) in
scientific/life-sciences or related field.
Requires 5+ years' experience in regulatory affairs.
Experience in regulatory commercialization for rare disease and
accelerated approval products is highly preferred.
Keywords: NS Pharma, Inc., Paterson , Manager Regulatory Commercial, Executive , Paramus, New Jersey
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