Chemistry Manufacturing and Controls, CMC

The Company – Syner-G Pharma Consulting, LLC:

  • A dynamic, entrepreneurial and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
  • Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
  • Distinguish ourselves by our passion for creativity and innovation
  • Offer flexible work environment allows for on-site, off-site and virtual-office scenarios
  • Clients include national and multinational pharmaceutical companies

General Description:

This position is a 6-month contract position with one of our pharmaceutical clients based in an area South of Boston. The Temporary Project Manager coordinates and prioritizes the tracking of the company’s regulatory activities. The Project Manager facilitates the Health Authority submissions associated with research, development and post-marketing for the targeted therapeutics areas. The dynamic Project Manager is the key player ensuring the success of the regulatory teams and furthering the vision of advancing novel therapies for rare and inflammatory fibrotic diseases.

Responsibilities and Duties:

  • Prepare and maintain detailed timelines for key global Regulatory Affairs activities and submissions, including INDs, IMPDs, NDAs (eCTDs) and other submissions as needed
  • Create and manage Regulatory Affairs projects and other various activities to establish and meet timelines within Regulatory Affairs. Manage projects across multiple disciplines including Clinical Development, Preclinical Development and CMC
  • Develop strong communications between the various groups in the Regulatory Affairs Department in order to facilitate timely problem solving and maintenance of important timelines
  • Must possess knowledge of regulatory requirements specific to the United States and the European Union, a general awareness of current global and regional trends in Regulatory Affairs is strongly preferred
  • Perform document quality control checks in accordance with established processes and coordinate meetings with internal teams and Sponsors

Required Skills and Experience:

  • 2-5 years of relevant project management experience required
  • BA degree in a Health or Scientific field, PMI or Advanced Degree is a plus
  • Ability to work on several projects with tight timelines and remain organized
  • Experience with IND, BLA, NDA, MAA with a strong understanding of the overall drug development process
Job Category: Project Manager
Job Type: Full Time

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