Director, Regulatory Affairs

4 months ago

Atlanta, United States Daiichi Sankyo, Inc. Full time

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 17,000 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

This role offers the opportunity to substantially contribute to the mission of Daiichi Sankyo in leveraging our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer.

This role will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company’s growth, thereby accomplishing corporate goals.

Responsibilities:

  • Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.
  • Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences with FDA
  • Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.
  • Participate in global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.
  • May serve as the single regulatory representative on study teams.
  • Review and interpret regulatory guidelines.

Continuing Education:  Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions.

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 required.
  • Advanced degree (e.g., Masters, PharmD., Ph.D., MD, JD) preferred.

Experience Qualifications:

  • 10 or More Years in the pharmaceutical industry required.
  • 7 or More Years in regulatory affairs
  • Experience in providing regulatory strategic input into the drug development process with thorough knowledge of the IND and NDA/BLA processes.
  • Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable. (s)NDA/BLA filing to FDA considered a plus.

Competencies:

  • Excellent oral and written communication skills, strong interpersonal skills; ability to work in a team environment; can work in high stress and deadline driven environment. Energetic, self-motivated and multi-task-oriented person.
  • Proactive, disciplined, organized and detail oriented. Attention to detail is required.
  • Demonstrates ability to think logically and objectively when identifying significant problems and opportunities.

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.

  • Regulatory Affairs Strategy Director

    1 month ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    Legacy of InnovationDaiichi Sankyo Group is dedicated to creating innovative pharmaceutical therapies to improve standards of care and address unmet medical needs globally. With over 100 years of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 16,000 employees draw upon a rich legacy of innovation and a robust pipeline of...

  • Regulatory Affairs Expert

    4 weeks ago

    Atlanta, Georgia, United States Accordance Search Group Full time

    Accordance Search Group is seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices, and preparing and submitting regulatory submissions in...

  • Principal Regulatory Affairs Specialist

    3 months ago

    Atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...

  • Principal Regulatory Affairs Specialist

    3 months ago

    atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...

  • Principal Regulatory Affairs Specialist

    3 months ago

    atlanta, United States Accordance Search Group Full time

    Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting...

  • Regulatory Affairs Strategist

    3 weeks ago

    Atlanta, Georgia, United States Accordance Search Group Full time

    Job DescriptionAccordance Search Group is seeking a talented Regulatory Affairs Strategist to join our team.The successful candidate will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices, and preparing and submitting regulatory submissions in the US,...

  • Product Stewardship and Regulatory Affairs Specialist

    1 month ago

    Atlanta, United States Kemira Full time

    Kemira is a global leader in sustainable chemistry for water intensive industries. For more than 100 years, our chemistry has advanced human progress and quality of life. We call it chemistry with a purpose, better every day. At Kemira, we foster a collaborative and inclusive work culture that empowers our employees to thrive and make a difference. Learn...

  • Product Stewardship

    1 month ago

    Atlanta, United States Kemira Full time

    Job DescriptionJob DescriptionKemira is a global leader in sustainable chemistry for water intensive industries. For more than 100 years, our chemistry has advanced human progress and quality of life. We call it chemistry with a purpose, better every day. At Kemira, we foster a collaborative and inclusive work culture that empowers our employees to thrive...

  • Global Regulatory Affairs Labeling Expert

    1 month ago

    Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full time

    Job SummaryThis role serves as the Global Regulatory Affairs Labeling Expert to the Global Regulatory Team, providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads. The successful candidate will manage multiple assigned projects of increased complexity, including post-marketing projects and those...

  • Associate Director of Local Government Affairs

    4 weeks ago

    Atlanta, Georgia, United States Emory HealthcareEmory University Full time

    Job SummaryThe Associate Director of Local Government Affairs coordinates and administers a robust advocacy program at the local government level for city and county municipalities in which Emory has a presence. This role requires a strong understanding of legislative, budget, and regulatory issues, as well as excellent communication and project management...

  • Associate Director, US Regulatory Affairs Strategy

    2 weeks ago

    Atlanta, United States Daiichi Sankyo, Inc. Full time

    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...

  • Associate Director, US Regulatory Affairs Strategy

    4 months ago

    Atlanta, United States Daiichi Sankyo, Inc. Full time

    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...

  • Associate Director of Local Government Affairs

    4 weeks ago

    Atlanta, Georgia, United States Emory University Full time

    Job SummaryEmory University seeks a skilled professional to serve as the Associate Director of Local Government Affairs. This role will coordinate and administer a robust advocacy program at the local government level for city and county municipalities in which Emory has a presence.Key ResponsibilitiesTrack all local government activity, including attending...

  • Associate Director of Local Government Affairs

    4 weeks ago

    Atlanta, Georgia, United States Emory HealthcareEmory University Full time

    Job SummaryThe Associate Director of Local Government Affairs coordinates and administers a robust advocacy program at the local government level for city and county municipalities in which Emory has a presence. This role requires a strong understanding of legislative, budget, and regulatory issues, as well as excellent communication and project management...

  • Associate Director of Local Government Affairs

    4 weeks ago

    Atlanta, Georgia, United States Emory HealthcareEmory University Full time

    Emory University seeks a skilled Associate Director of Local Government Affairs to coordinate and administer a robust advocacy program at the local government level for city and county municipalities in which Emory has a presence.The ideal candidate will have a strong understanding of local government and civic leaders, as well as excellent communication and...

  • Associate Director, US Regulatory Affairs Strategy

    3 weeks ago

    Atlanta, GA, United States Daiichi Sankyo, Inc. Full time

    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...

  • Associate Director, US Regulatory Affairs Strategy

    3 days ago

    Atlanta, GA, United States Daiichi Sankyo, Inc. Full time

    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...

  • Chief Counsel for Health Affairs

    1 month ago

    Atlanta, Georgia, United States ACC - Association of Corporate Counsel Full time

    Job Title: Chief Counsel for Health AffairsEmory University's Office of the General Counsel is seeking a highly experienced and skilled Chief Counsel for Health Affairs to oversee all legal matters for Emory Healthcare and serve as the primary legal advisor to Emory Healthcare's CEO, senior management team, Board of Directors, and more than 490 outpatient...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Atlanta, Georgia, United States Abbott Laboratories Full time

    Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Regulatory Compliance Manager

    2 months ago

    Atlanta, United States Seneca Resources Full time

    Title: Manager, Regulator Affairs & ComplianceLocation: Atlanta, GADuration: FTE, Direct Hire As the Manager, Regulatory Affairs & Compliance, you will assist and support the company by liaising with internal and external stakeholders on matters of regulatory compliance. Assist the Director with strategic direction and contribute to the business-wide...