Current Statistics
1,566,409 Total Jobs 319,468 Jobs Today 16,491 Cities 222,697 Job Seekers 146,732 Resumes |
|
|
|
|
|
|
Director, Global Regulatory Affairs (GRL) - Atlanta Georgia
Company: Daiichi Sankyo, Inc. Location: Atlanta, Georgia
Posted On: 05/19/2024
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: |
|
|
|
|
|
|
Copyright 2024 LocalJobBoard.com. All Rights Reserved.
RSS Job Feeds
Director, Global Regulatory Affairs (GRL): Atlanta, Georgia job search information from LocalJobBoard.com
Recruiter expertise by Recruiter Media Corporation
Job Offers Search Engine
Atlanta Georgia job: Director, Global Regulatory Affairs (GRL), Atlanta Georgia job search
|