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Daiichi Sankyo
Atlanta, GA, United States
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise a
Job Source: Daiichi SankyoAzurity Pharmaceuticals - US
Atlanta, GA, United States
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad com
Job Source: Azurity Pharmaceuticals - USConfidential
Atlanta, GA, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Geno
Job Source: ConfidentialConfidential
Atlanta, GA, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA interact
Job Source: ConfidentialImbria Pharmaceuticals
Atlanta, GA, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsImbria Pharmaceuticals
Atlanta, GA, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsArxada
Atlanta, GA, United States
Posted Job Advert Arxada is a global specialty chemicals business that's committed to solving the world's toughest preservation challenges through better science. With a proud history of innovation dating back more than a century, we aim to help our customers develop more sustainable solutions that protect and maintain the health and wellbeing of
Job Source: ArxadaPiper Companies
Atlanta, GA, United States
Piper Companies is searching for an Experienced Regulatory Affairs Professional in Advertising & Promotion to lead the neurology regulatory affairs team of a global biopharmaceutical company as Associate Director of Regulatory Affairs (Advertising & Promotion). The position is a remote opportunity.Responsibilities for the Associate Director of Regu
Job Source: Piper CompaniesAtlanta, GA, United States
Direct the activities of US Labeling and Advertising/Promotional Review Teams. Responsible for the oversight of labeling for product registration and commercialization.Ability to provide Advertising/Promotional regulatory insight in line with applicable regulatory guidelines. Serve as a liaison and subject matter expert (SMA) on the interpretation of US Labeling and Advertising/Promotional FDA guidance documents and regulations.
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, andwritten communication skills, strong grammar, andproofreading/editing skills, and MS Office skills are required.
Knowledge of pharmaceutical labeling, packagingcomponents, graphic arts capabilities (ADOBEIllustrator/XML), and SPL labelingprocess.
Track record of successfully working with third-partyvendors.
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 environmentand circumstances requiring flexibility, toleranceand great sense of urgency while ensuring that allcGMP and regulatory requirements aremet.
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, andwritten communication skills, strong grammar, andproofreading skills.
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Email Alert for Director, Regulatory Affairs jobs in Atlanta, GA, United States
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