Title: Associate Director – Regulatory Affairs, Advertising & Promotion
Location: Edison, NJ/Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
The Associate Director, Regulatory Affairs Advertising and Promotion will provide strategic input into the review and approval of effective commercial campaigns and pre-commercialization activities that are compliant with FDA regulations and internal TG standards. This person will serve as the regulatory lead on the Multiple Sclerosis Medical, Legal, and Regulatory (MLR) review committee and will report to the Senior Director, Regulatory Affairs Advertising and Promotion.
Responsibilities include but are not limited to:
––Representing the Regulatory function in the review and approval of promotional, medical, or educational materials for investigational or marketed products in MLR
––Providing regulatory strategy on promotional materials and activities, including the development of disease awareness campaigns and product launch materials, in compliance with FDA regulations and TG Therapeutics internal policies
––Develop working relationships with OPDP reviewers and oversee the timely and accurate submission of promotional materials to OPDP
––Keep current in the areas of regulatory, healthcare compliance and ethics
––Develop and maintain strong working relationships with internal cross functional partners
––Manage other departmental projects and other deliverables as required
– Serve as the disease area expert and providing support to cross functional team members, including onboarding and review of materials
––We are looking for an individual that is highly motivated, solutions oriented and a team player. We value someone who has exceptional communication skills and can collaborate successfully with cross-functional partners
––A track record of working on launching products is highly desirable.
––Experience in immunology or neurology preferred
––Direct experience working with OPDP preferred
––Ability to propose regulatory advertising and promotion strategies for promotional campaigns, disease awareness, and institutional campaigns
––Proven aptitude to analyze and interpret clinical data
––Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration
Can travel domestically and internationally approximately 25% of the time (post-pandemic).
• Willingness and ability to travel domestically and internationally, as required.
Bachelor’s degree in science (biology, chemistry, immunology, pharmacy, nursing, pharmacy); advanced degree preferred (MS, PhD, PharmD, JD)