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Azurity Pharmaceuticals - US
Atlanta, 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
Job Source: Azurity Pharmaceuticals - USAzurity 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
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: ConfidentialConfidential
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: 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 cell’s 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 cells 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
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 and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease of review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback from the regional strategists in terms of HA meetings globally. Responsible for representing GRA in the GPT (Global Project Team) as well representing the project team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre-clinical groups, Regulatory CM&C and other appropriate group within the company as needed.
Responsibilities
Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products.
Seeks and incorporate regional and functional RA strategy into a global strategy.
Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.
Serve as a leader of the GRT (Global Regulatory Team)
The primary point of contact with Alliance Partners Joint-RA teams and Joint-GPT as applicable.
Supervises the identification and compilation of required documentation for submission. Prioritizes workload as necessary.
Keeps current with latest Health Authority guidelines and provides Regulatory advice to members within Regulatory, and various associated departments within the Company. Also communicates with outside consultants (i.e. CRO’s) as needed.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Bachelor's Degree preferably in a scientific discipline required.
Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred.
Experience Qualifications:
4 or More Years of proven experience in a regional regulatory lead role
7 or More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs
Knowledge of IND, NDA/BLA submission experience
Experience with regulatory submission strategy globally will be preferred but not required.
Experience in providing regulatory strategic input into the Oncology drug development preferred.
Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable.
Experience with CTD/eCTD preparations preferred.
Travel
Ability to travel up to 30% In-house office position that may require occasional travel (global).
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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Email Alert for Director, Regulatory Affairs jobs in Atlanta, GA, United States
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