Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
The Director Regulatory Affairs Advertising and Promotion is responsible for the regulatory review, submission and approval of materials related to labeling and advertising /promotion; ensuring compliance with internal SOPs and FDA requirements and providing regulatory guidance and intelligence to support commercialization strategies.
Determine and provide strategic regulatory advice on advertising and promotion materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives.
Works collaboratively with internal customers; including Marketing, Legal and Medical Affairs as part of the Materials Approval Process (MAP)Promotional Review Committee
Supports compliance with internal SOPs and FDA requirements with timely and accurate review of materials related to labeling, advertising and promotional material of brand and generic drug products to meet internal timelines and requirements as well as final approval/disapproval
Liaise with Health Authorities (e.g., FDA OPDP), as needed, and submit materials to OPDP.
Monitors and maintains up-to-date knowledge of laws, regulations and policies enforced by the FDA as they relate to labeling, advertising and promotion of pharmaceuticals and provides regulatory advice and updates internal stakeholders accordingly.
Monitors competitor advertising to keep abreast of market promotional and advertising strategies, and assesses potentially violative competitive materials for forwarding to OPDP as appropriate.
Communicates with consultants, attorneys and external parties as needed.
Participate as needed in training of sales and marketing personnel on promotional, marketing, labeling and advertising regulations.
Work with other regulatory team members to provide input into improvement of systems and/or processes including support for the development of department SOPs or work instructions.
Demonstrates expert knowledge of labeling guidance and manages compliance with labeling regulations and guidelines.
Coordinates labeling activities with multifunctional contributors, reviews package inserts, cartons and labels for compliance with regulations with regard to both content and format.
Ensures inserts, cartons and labels of marketed products comply with current guidelines as needed and that changes in the US Package Insert are appropriately implemented and reflected in current promotions and advertising.
Provides input and strategic guidance to the development of Target Product Labels for development projects.
Provide training or guidance to new or junior staff as needed.
The incumbent in this position may be required to perform other duties, as assigned.
Strong capability to work in a team matrix environment
Ability to read, analyze, interpret and integrate scientific and technical information
Business acumen and the ability to see business drivers outside of regulatory affairs
Excellent communication skills, both oral and written
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Detail-oriented with the ability to proofread and check documents for accuracy as well as consistency
Education / Experience:
Bachelor’s degree in pharmacy, life sciences, nursing, or equivalent. Masters or PharmD or other advanced degree is preferred.
Experience as a member of Promotional and or Scientific/Medical materials review committee(s) as a reviewer.
3 years of regulatory affairs relevant experience in labeling, advertising and promotion. Minimum of 5 years of relevant industry experience.
Experience with the use of Veeva Vault and electronic submissions to OPDP
Knowledge of and experience interacting and negotiating with regulatory agencies, particularly OPDP.
Knowledge of transdermal products and/or relevant therapeutic areas (psychiatry, pain, Women’s health,) is desirable.
Additional Salary Information: Competitive Base Salary, Annual Bonus, Long Term Incentive Plan
Internal Number: 00541
About Noven Pharmaceuticals, Inc.
Noven Pharmaceuticals, Inc. is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. We are committed to developing and offering pharmaceutical products that meaningfully benefit patients, with a commitment to advancing patient care through transdermal drug delivery.
Over 325 Noven colleagues are working to advance our business and benefit patients at locations in Miami, FL and Jersey City, NJ. We are a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., the world’s largest manufacturer of transdermal patches, and we serve as Hisamitsu's platform for U.S. prescription pharmaceuticals, helping Hisamitsu bring the benefits of patch therapy to the world.
Noven maintains state-of-the art, FDA-approved transdermal manufacturing facilities in Miami with capacity to produce several hundred million patches per year. These facilities are also approved by the U.S. DEA (Drug Enforcement Agency) for the production of controlled substances.
Noven’s commercialized transdermal products include Minivelle® (estradiol transdermal system), the planet’s smallest estrogen patch; Combi...Patch® (estradiol/norethindrone acetate transdermal system), the first approved combination (two-drug) patch; Daytrana® (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD. Noven's commercialized products are marketed through Noven Therapeutics, LLC. Noven's authorized generic division, Grove Pharmaceuticals, offers our products to the generic marketplace as Authorized Generics.
Noven’s product development pipeline includes a range of prescription transdermal products that utilize Noven’s advanced transdermal delivery technology.