Manager, Regulatory Operations Dossier Planning in Bernards, NJ at DSI

Date Posted: 11/14/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

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

1. 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
2. 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.
3. Assists in the writing of departmental SOPs.

Qualifications

Education
  • Bachelor’s degree in Life Sciences, or equivalent experience, is essential.
Experience
  • Experience in the pharmaceutical industry with at least four to six years regulatory operations experience. High degree of knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers is required. Past experience in regulatory submission planning is a plus. Working knowledge of drug laws, regulations and guidelines is essential.
Competencies
  • A thorough knowledge and understanding of Health Authority regulations, guidance documents and the drug development process is required. The ability to plan and manage multiple, complex dossier plans simultaneously is required. Self-sufficient, self-motivated, excellent leadership skills, able to prioritize and delegate, detail-oriented, good interpersonal skills, ability to effectively communicate in writing and orally with peers and upper management.
  • Advanced computer skills (MS Word, Excel, Project and Adobe Acrobat) are vital. Understanding of templates and authoring tools is a plus.
  • Electronic publishing experience – e.g., InSight Publisher, ViewPoint, eCTD Reviewer, Documentum, etc. is a plus.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.