Duties & Responsibilities: Responsible for providing commercial regulatory strategy and leadership for promotional materials. Advise internal teams and management on regulations, guidance, and industry best practices related to product labeling and advertising/promotional components. Perform regulatory review of advertising and promotional materials, as required. Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies, required documentation and regulatory risks. Lead the MLR (medical, legal, regulatory) review committee for advertising and promotional components. Knowledge of submission process for promotional components to FDA\'s Office of Prescription Drug Promotion (OPDP). Excellent organizational, interpersonal, verbal, and?written communication skills, strong grammar, and?proofreading/editing skills, and MS Office skills are required. Knowledge of pharmaceutical labeling, packaging?components, graphic arts capabilities (ADOBEIllustrator/XML), and SPL labeling?process. Track record of successfully working with third-party vendors. Create/revise SOP?s and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes. Continuously monitor the regulatory environment for new regulations, guidance, and enforcement. Recruit, develop and act as an advisor and coach to direct reports and junior members of the regulatory team. Ability to rapidly adapt to changing environment?and circumstances requiring flexibility, tolerance?and great sense of urgency while ensuring that all?cGMP and regulatory requirements are?met?. Qualifications: Bachelor?s degree in Life Science or other related discipline. At least 10 years? experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review. A combination of education and applicable job experience may be considered. Experience leading team members, fostering a culture of efficiency and teamwork. Demonstrated track record of successful product launches. Strong expertise and knowledge of Advertising/Promotional regulations and guidance. Excellent organizational, interpersonal, verbal, and?written communication skills, strong grammar, and?proofreading skills.? Azurity Pharmaceuticals
...tailored to each child's unique needs, focusing on self-management, language, learning, and social skills. Through an ABA approach combined with therapies and education, TLS helps children thrive in settings where they can reach their full potential. RESPONSIBILITIES...
...Roofing Outside Sales Sales Full-Time Commission Range: $80000 - $150000 year Join Our Roofing Team!! Position: Roofing Outside Sales At Axis Roofing, were dedicated to providing top-notch roofing solutions with unparalleled customer service. Were a team...
...Traveling with a coworker in company trucks to customers' homes and commercial properties. Cleaning Exterior Windows, Pressure Washing, Gutter Cleaning and Roof Washing in a safe and professional manner according to the techniques and best practices learned during training...
...Certified Occupational Therapist Assistant ~ COTA La Villa Grande Care Center ~ Grand Junction, CO Skilled Nursing Community Pay Rate - $27Hr - $38Hr DOE - Full, Part Time & PRN BENEFITS OFFERED - Health, Vision, and Dental Insurance. 401(k) with company match...
...Job Description Job Description Saltz Matkov P.C.'s Wayne, PA office has a position available for a full-time or part-time associate attorney with 2-4 years experience in professional liability, commercial and insurance coverage litigation. Successful candidates...