Associate Director, Regulatory Affairs, Advertising & Promotion New Jersey
Tanner and Associates is recruiting an Associate Director, Regulatory Affairs, Advertising & Promotion for a Pharmaceutical Company.
This Job is located in New Jersey.
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.
Responsibilities :
- Provides strategic and operational leadership in advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy
- Serves as the company’s regulatory reviewer for assigned products and the liaison to FDA Division of Drug Marketing, Advertising and Communications (DDMAC)
- Works closely with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotional materials to support the commercial interests of the business and comply with applicable FDA regulations
- Represents Regulatory Affairs on the company’s Promotional Review Committee and provides guidance on current regulatory environment and regulatory considerations that may impact business activities
- Trains company personnel as it pertains to regulatory aspects of advertising and promotion, especially in the area of exhibit booth activities
- Provides recommendations to Medical Affairs Teams on Phase IV clinical trial design regarding promotability of potential data / claims
- Works with US Regulatory Manager on International Product Teams to insure that regulatory strategy will result in commercially viable US labeling in which future promotion and advertising will be affected
- Participates in US labeling negotiations and FDA meetings as necessary
- Ensures that changes in US prescribing information are reflected in current promotion and advertising
Requirements :
- PhD or PharmD with 4-6 years of related industry experience; or, FDA or MS degree with 7-10 years industry experience; or, BS degree with 12 years industry experience, including 2 + years of local regulatory experience
- Experience in regulatory review of professional and consumer Rx drug advertising and promotion
- Experience in leading activities necessary for promotional DDMAC submissions (including pre-clearance time of first use submissions)
- Experience with regulatory activities involved with a product launch; and an understanding of business goals of the involved business franchise, marketing concepts and tools
- Track record of demonstrated leadership skills and ability to interact with management
- Excellent written and verbal communication abilities are essential
- Expert knowledge of the pharmaceutical business and proficiency at representing / interpreting the strategic business objectives of the company
J-18808-Ljbffr
Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance
As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. The Director will also ser...
Dermatology Physician - Dermatologist Healthcare Cherrry Hill, New Jersey
Current state of New Jersey or eligible Physician license. Dermatology Physician Job Opportunity in the Jersey Shore area. Located right on the Jersey Shore, the area offers residents easy access to beautiful beaches and stunning views of the Atlantic Ocean. It is 65 miles to New York City, 95 miles...
Primary Care/Medical Director Opportunities (2) in New Jersey - Next to NYC!
Primary Care/Medical Director Opportunities (2) in New Jersey – Next to NYC!!. We are seeking Board Certified Internal Medicine & Family Medicine physicians for Medical Director positions located in great areas just minutes from downtown NYC. ...
Medical Director - New Jersey Market
Preferred candidates will reside in New Jersey and have a NJ License without encumbrances or the ability to obtain a NJ License. In the Medical Director role you will provide oversight for medical policy implementation. As a Medical Director you will focus primarily on overseeing utilization review/...
Medical Director of Mechanical Circulatory Support – Cardiology - Physician - Valley Medical Group, New Jersey
Licensed physician in the State of New Jersey and New York. The Valley Health System is seeking a visionary and experienced Medical Director of Mechanical Circulatory Support in Bergen County, NJ. The Medical Director of Mechanical Circulatory Support will play a pivotal leadership role within the V...
Cashier - Service Associate PT
Become a Rite Aid Service Associate, today! As a Service Associate, you are responsible for the day-to-day operations, care, and service provided to our customers & patients. Service Associate Contribute to our mission to improve Health and Wellness in your community. Day-in-the-Life of a ...
Sales Associate – New Jersey
Lee & Associates – New Jersey is now seeking JUNIOR AGENTS. Lee & Associates – New Jersey, LLC, a commercial real estate brokerage firm,. Lee & Associates is seeking entry level and junior real estate agents. ...
Global Regulatory Strategy, Associate Director
The Associate Director, Global Labeling Strategy for Early Asset has overall accountability for initial creation and relevant updates to labeling documents (Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmP...
Patient Services Associate Float - Jefferson New Jersey
The Patient Services Associate (PSA) I enhances the patient/customer experience by courteously and professionally processing arrival and departure activities associated with visits to the practice/department. Nationally ranked, Jefferson, which is principally located in the greater Philadelphia regi...
Geriatrics/Medical Director Opportunities in Southern New Jersey/Suburban Philadelphia!!
Geriatrics/Medical Director Opportunities in Southern New Jersey/Suburban Philadelphia!!. Our Medical Directors oversee the medical staff at our owned and managed skilled nursing centers and, when appropriate, assisted living communities. Medical Directors may choose between Independent Contractor a...