Manager, Advertising & Labeling US Regulatory Affairs
Location: Parsippany New Jersey
Description: Ferring Pharmaceuticals, Inc. is currently interviewing Manager, Advertising & Labeling US Regulatory Affairs right now, this vacancy will be placed in New Jersey. For complete informations about this vacancy opportunity please give attention to these descriptions. Ferring Pharmaceuticals is a private, research-driven specialty biopharmaceutical company active ! in global markets. The company identifies, develops and markets innovative products in the fields of endocrinology, gastroenterology, infertility, obstetrics, urology and osteoarthritis. In recent years Ferring has expanded beyond its traditional European base, with over 4,500 employees worldwide, it operates subsidiaries in over 50 countries and makes its products available in more than 90 countries.
This position will be the Regulatory representative on the LMR (Legal, Medical, and Regulatory) for the review and approval of advertising and promotion campaigns and pre-commercialization activities.
Contribute to the development and implementation of a regulatory labeling strategy and documentation for marketed products and products in development (pre-launch). This person will serve as the US Regulatory Labeling representative on relevant project teams to provide strategic input into the development and approval of all product labels and provide oversight ! for the implementation of new labels for marketing.
E! SSENTIAL DUTIES AND RESPONSIBILITIES include the following
1. Lead cross-functional teams in the development and lifetime maintenance of labeling. Represent labeling group on product sub teams, communicate key strategy and ensure labeling positions are appropriately represented
2. Responsible for the implementation of new or revised labeling for certain products by working with the Regulatory lead.
3. Ensure consistency of labeling across product lines and compliance with Ferring policies and procedures whilst remaining compliant with text and labeling approved in NDA or ANDA applications.
4. The Regulatory member of the Legal, Medical and Regulatory team (LMR) for the review and approval of all advertising and promotional materials, concept reviews and pre-commercialization materials for products in collaboration with commercial, clinical and legal to ensure that they comply with FDA regulations. Launch experience a plus.
5. Mai! ntain up to date information regarding initiatives by FDA and other applicable regulatory authorities relating to labeling, advertising and promotion
6. Act as liaison with Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Advertising, Marketing and Communications (DDMAC) for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for review by FDA)
7. Provide updates on new FDA guidance or trends, the issuance of enforcement letters by FDA or competitor product FDA correspondence.
8. Assist in the review and approval of materials developed by various functions within the U.S. organization that will be disseminated to health care professionals and the general public relating to Ferring products and compounds (e.g., sales training, press releases, and Speakers’ slide decks).
Qualification and Experience Requirements
A degree in Life S! ciences or equivalent
Advanced degree preferred.
A minimum of 5! years of Regulatory Affairs experience is required. 3+ years experience in advertising and labeling is also required.
Must have previous experience interacting with the FDA. Excellent communication and collaboration skills are required.
The above is intended to describe the essential job functions and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
- .
If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Ferring Pharmaceuticals, Inc..
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Tue, 07 May 2013 06:53:00 GMT
Apply Manager, Advertising & Labeling US Regulatory Affairs Here