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Mgr Regulatory Operations Publishing in Bernards, NJ at DSI

Date Posted: 4/25/2019

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 Manager, Regulatory Operations Publishing will be responsible for managing the planning and delivery of regulatory submissions required to support the development and registration of new products for global applications.
This will be demonstrated by leading focused Submission Publishing teams while directing the creation of the dossier and ensuring that all aspects of the plan are coordinated and executed efficiently.
Additionally, the Manager, Regulatory Operations Publishing will be expected to provide guidance to project teams regarding submission standards and processes, as well as interface with clinical, pre-clinical, CMC and other key contributors to resolve various submission issues.
Additionally the role is responsible for ensuring timely communication between R&D business users and the Information Technology (IT) group in order to facilitate the development and/or improvement of electronic systems used by business users in the creation and delivery of regulatory submissions in accordance with ICH and FDA requirements. Provide publishing support as a tertiary responsibility

Responsibilities
  • Manages the submission process from initiation through to approval and dispatch for major, minor and regular maintenance Regulatory submissions (IND, NDA, BLA, Agency Responses, others).
  • Monitors submission mailbox and works with publishing resources to ensure assignment (internal & contractor)
  • Directs submission quality process and provides resolution guidance
  • Attend submission planning meetings with business users, as needed, to ensure communication of system issues, standards.
  • Provide technical support to business users for questions regarding publishing software and eDMS applications and liaises with IT regarding system issues.
  • Liaise with IT staff and vendors to assess, recommend, test and implement technologies that would facilitate the regulatory submissions process.
  • Participates in system evaluation and validation testing representing business operations. Reviews and approve documents such as electronic systems protocols, (OQ/PQ) testing and execution documents related to regulatory submissions, ensuring that business needs are properly addressed.
  • 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 submission process development and improvement activities including the writing of departmental SOPs.
  • Assist with the publication of regulatory submissions as needed. Also assist in ensuring submission-readiness of documents for publication and in conducting quality checks of submissions.


Qualifications

Education and Experience
  • BA/BS degree in Information Technology/Life Sciences or related field
  • Experience in the pharmaceutical industry with at least four to six years regulatory operations (publishing) 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 regulations and guidelines defining submission activities is essential.
  • 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., docuBridge,, Lorenz eValidator, , Veeva Vault, 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.