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Manager Regulatory Commercial

Company: NS Pharma, Inc.
Location: Paramus
Posted on: May 13, 2022

Job Description:

Job Summary
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 comments.
Maintain Veeva system and keep-up-to date and ensure compliance.
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 based
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 risks.

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 responsibilities.
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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