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66523128 Director, Regulatory Affairs, Advertising and Promotion - Parsippany, NJ

Job Information

ID :
#37972088
# of Positions :
1
Minimum Education Level :
Unspecified
Experience Required :
7+ years
Duration :
Full Time Regular
Shift :
Unspecified
Hours per week:
40

Job Description

 

About Ferring:By building strong relationships within the scientific community, our medical affairs team has become a trusted partner among patient groups, clinicians and health policy decision makers. We pride ourselves on developing and disseminating information to our key stakeholders so that they can provide the best care for our patients. Because we oversee the entire lifecycle for many of our products, we're on the forefront of developing valuable and scientifically grounded information that will chart exciting paths forward for many of our innovative brands. Join our expert team and drive innovation.Job Description:Contribute to outstanding innovation + Make braver choices

Director, Regulatory Affairs, Advertising and Promotion

Location: Parsippany

As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our 'people first' philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

Summary:

Purpose of role is to provide US Regulatory leadership, oversight, and guidance to extended commercial therapeutic brand teams, in the commercialization activities associated with the advertising and promotion of approved products to ensure compliance with product registrations and regulatory requirements throughout the product life-cycle and serve as the designated Regulatory Responsible Official for all FDA submissions of regulated promotional materials to FDA for key therapeutic areas.

Responsibilities:
Provide regulatory leadership to the respective cross-functional Legal, Medical Regulatory (LMR) team charged with review and approval of all advertising and promotional materials and programs throughout product life cycle to ensure compliance with applicable laws, regulations and Company policies. Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks. Manages submissions of promotional materials to FDA . Signatory as Ferring's Responsible Regulatory Official on FDA FORM 2253 submissions for assigned products. Acts as primary contact with FDA's Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material.
Liase with Commercial Brand team during the brand planning process on proposed strategic promotional programs and tactics for the upcoming year; Provide consistent, well-supported, and clear guidance to stakeholders related to Regulatory strategy during the brand planning process and through implementation of the brand plan to ensure promotional goals can be achieved.
Provide strategic input on updates to FDA approved labeling for current marketed products and proposed labeling for products in development (pre-launch) in the capacity as the ad hoc US Regulatory Ad/Promo labeling representative on relevant Labeling Committee project teams. Liase with Commercial team to drive strategy to implement updated labeling for currently marketed products, as it relates to LMR approved promotional materials.
Ensure consistent application of FDA advertising and promotion regulations, and guidances across product portfolio lines and compliance with Ferring policies and procedures whilst remaining consistent with labeling approved in NDA/ANDA applications or other marketing authorization.
In collaboration with Regulatory Operations, ensure the management and maintenance of accurate and complete records and databases that support communication with FDA Office of Prescription Drug Promotion (OPDP).
In conjunction with department leadership team, participate in development, implementation and maintenance of regulatory policies and procedures regarding review of advertising and promotional materials for marketed products and pre-commercialization materials for products or uses prior to FDA-approval.
Maintain up to date information regarding regulations, guidelines or other initiatives by FDA and other applicable regulatory authorities relating to labeling, advertising and promotion and coordinate regulatory training of commercial, medical and marketing teams, as needed, on regulatory issues pertaining to advertisement, promotion and product launch activities.
Coordinate regulatory processes with Regulatory counterparts at Business Development Alliance Partners of in-licensed products and/or co-promotion partners to align regulatory review, approval and submission processes to ensure fulfillment that regulatory obligations are met.
Maintain databases of OPDP regulatory submission documents as created and approved by the LMR and serve as back up local administrator for the global document management software platform.

Requirements:
BS/BSc is required. Advanced scientific related degree: Pharmacy or Clinical Science or law degree preferred.
10+ years pharmaceutical or related industry; inclusive of > 8 years Regulatory or related experience. FDA experience preferred.
Ex-FDA or demonstrated years of success in working with FDA's Office of Prescription Drug Promotion.
Experience in managing multiple filings e.g. Launch Advisory Materials or responses to enforcement letters. Promotion and Advertising experience in multiple therapeutic areas.
All required FDA submissions properly and timely made upon initial dissemination of LMR approved advertising and promotion.
All advertising and promotional materials approved in compliance with company policies and procedures.
Regulatory issues are resolved expeditiously with stakeholders and with infrequent need for Executive Committee escalation.
No FDA enforcement letters issued related to advertising and promotional materials.
Must have deep understanding of sciences leading to approval of drugs, biologics, and devices (and combination products).
Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate.
Solid understanding of business goals and common marketing concepts/tools, including the internet and social media and other digital marketing platforms.
Expert understanding of FDA advertising and promotion regulations and guidelines specific to advertising and promotion of pharmaceutical products.
Flexible, dynamic, and entrepreneurial.
Supports culture of performance and accountability.
Ability to foster collaboration amongst team members.
Excellent written and oral communication skills.

Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation.

Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.

We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location:Parsippany, New Jersey

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

Company Information

Name :
Ferring Pharmaceuticals Inc.
Description :
pharmaceutical preparations (except biological) 
Type :
Direct Employer
Address :
100 Interpace Parkway
Parsippany, NJ 07054

Application Information

Online :
Job Posting Entered On :
5/4/2022
Job Posting Expires On :
8/2/2022