Director - Drug Regulatory Affairs - Novartis - New York

Job description
Novartis is recruiting for a Director for Drug Regulatory Affairs, Advertising and Promotion - Critical Care, located in East Hanover, NJ.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
The Director/Associate Director for Drug Regulatory Affairs, Advertising and Promotion - Critical Care will provide strategic regulatory advice on advertising and promotion materials and activities for assigned products in the Primary Care and Established Medicines in accordance with business goals and objectives, FDA regulations/guidance, PhRMA guidelines and company policy.

Major Activities:
•Serves as a primary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams.
•Liaison with OPDP regarding advertising and promotion for assigned products. Establishes strong and positive working relationship with OPDP reviewers.
•Manages OPDP queries on assigned products.
•Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues.
•Ensures regulatory compliance while effectively managing business risks.
•Understands global promotional strategies and provides solution to local US regulatory promotional issues.
•Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
•Provides training to Novartis representatives responsible for exhibit booth activities at these meetings. •Prepares complaint letters to OPDP.
•Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.
•Provides recommendations to Local Program Teams (“LPTs”) on phase IV clinical trial design with regard to promotability of potential data/claims.
•Works with US Regional Brand Regulatory Managers on Global Program Teams to insure that regulatory strategy will result in commercially viable US labeling upon which future promotion and advertising will be based.
•Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
•Participates in US labeling negotiations and FDA meetings as necessary.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired Skills and Experience
Position will be filled at level commensurate with experience.

•Minimum of a BA/BS Degree, Advanced degree preferable (MS, MD, PhD, PharmD, or JD).
•Minimum 5 years regulatory experience.
•Excellent knowledge and understanding of US regulations for drug promotion/advertising and US labeling.
•Experience in the regulatory review of professional and consumer Rx drug advertising and promotion.
•Proven ability to analyze and interpret efficacy and safety data.
•Experience in leading activities necessary for promotional OPDP submissions (including pre-clearance and 2253, “time of first use” submissions).
•Experience with regulatory activities involved with a product launch.
•Strong understanding of business goals of the involved business franchise, marketing concepts and tools.
•Must perform independently with strong problem solving, negotiation and decision making skills.
•Must possess strong interpersonal, collaboration and communication skills.

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status

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