Manager Dossier, Regulatory Operations

Location
Basking Ridge, NJ, United States
Posted
Mar 21, 2021
Ref
10712BR
Hotbed
Pharm Country
Required Education
Other
Position Type
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 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

Job Summary:

The role of the Dossier Manager, Regulatory Operation will primarily be responsible for managing the planning and delivery of regulatory submissions (IND, NDA, Agency Responses, others) required to support the development and registration of new products for worldwide customers.

This will be demonstrated by leading regionally focused Submission teams while directing the creation of the dossier and ensuring that all aspects of the plan are coordinated and executed efficiently.
Additionally, the Dossier Manager will be expected to provide guidance to project teams regarding document standards and processes, as well as interface with clinical, pre-clinical, CMC and other key contributors throughout the Company (as required) to resolve various submission issues.

Responsibilities:
  • Manages the submission process from initiation through to approval and dispatch for major Regulatory submissions (IND, NDA, Agency Responses, others).
  • Leads Submission Team meetings
  • Creates and maintains submission timelines using planning tool/software
  • Liaises with Publishing Specialists to ensure timely completion of publishing components for submissions
  • Advises on submission strategy and takes part in project team meetings
  • Provides guidance/training to the Submission Teams on internal document submission standards and processes
  • 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 (vendors, CRO's) as needed.
  • Assists in the writing of departmental SOPs.


Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor's Degree in Life Sciences, or equivalent experience required

4 or More Years' experience in the pharmaceutical industry with regulatory operations experience preferred

High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers required

Working knowledge of drug laws, regulations and guidelines required

Past experience in regulatory submission planning preferred


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.

Job Title
Manager Dossier, Regulatory Operations

City
Basking Ridge

Functional Area
Regulatory Management Operations

State
New Jersey