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GSK LLP
Columbia, MD, United States
Site Name: USA - Maryland - Rockville, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore Posted Date: Jun 11 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medi
Job Source: GSK LLPJohns Hopkins Medicine
Baltimore, MD, United States
Share This Page Job Details Requisition #: 639750 Location: Johns Hopkins Ambulatory Surgery Centers, Baltimore, MD 21201 Category: Leadership Schedule: Day Shift Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety a
Job Source: Johns Hopkins MedicineJohns Hopkins Medicine
Baltimore, MD, United States
Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification
Job Source: Johns Hopkins MedicineJohns Hopkins HealthCare
Columbia, MD, United States
Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certificatio
Job Source: Johns Hopkins HealthCareJohns Hopkins Medicine
Columbia, MD, United States
Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification
Job Source: Johns Hopkins MedicineEntrada
, MD, United States
We exist to help patients and their families live better lives. Our Values We love science and our values bind us together to create an environment that is as unique as our research. We are building a company culture where everyone can belong, contribute and grow. Join us. We connect to and are inspired by our mission to drive innovation and unloc
Job Source: EntradaDaiichi Sankyo
Baltimore, MD, United States
Director, US Regulatory Affairs Strategy in Basking Ridge at Daiichi Sankyo 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
Job Source: Daiichi SankyoDaiichi Sankyo
, MD, United States
Director, US Regulatory Affairs Strategy in Basking Ridge at Daiichi Sankyo 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 w
Job Source: Daiichi Sankyo, MD, United States
Director, Global Regulatory Affairs (GRL) in Remote at Daiichi Sankyo 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, Global Regulatory Affairs (GRL) jobs in , MD, United States
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