Collegium Pharmaceutical

Senior Manager, CMC

Job Locations US-MA-Stoughton
Posted Date 2 weeks ago(11/24/2021 12:14 PM)
ID
2021-1476
# of Openings
1
Category
Pharmaceutical Development

Overview

Collegium Pharmaceutical is committed to becoming the leader in responsible pain management. Our portfolio compels us to
step into the pain market at a time when others have opted to step out. We recognize the importance of earning the trust of
key stakeholders every day. We will continue to work hard to position Collegium to usher in a next generation of non-opioid
pain solutions in the US market. We remain focused on making a positive difference in the lives of people suffering from pain
and our communities.

 

 

POSITION OVERVIEW 

The Senior Manager will play a key role in CMC (Chemistry, Manufacturing, and Controls) operations across the organization
to execute the regulatory and operations strategy and support company initiatives. This role contributes to the day-to-day
operational activities of the department and ensures that performed tasks comply with regulatory and operations policies,
best industry standards and applicable regulations. They will manage the CMC activities including regulatory documents,
regulatory submissions, and projects.

Responsibilities

  • Lead CMC regulatory submissions including overall submission project, cross-functional communication, timelines,
    drafting (self- and cross-functional), editing, formatting, reviewing, and publishing for current CMC sections of existing
    NDAs plus related maintenance documentation (amendments, supplements, annual reports, etc.) for US and other
    Regulatory Health Authorities when required (Canadian and European).
  • Authors regulatory documents under minimal supervision and serves as in-house regulatory expert to internal and
    external stakeholders.
  • Develop the regulatory strategy and filing strategy for manufacturing, facility changes and R&D activities under
    minimal supervision.
  • Develop and maintain tools to effectively communicate the status of ongoing CMC regulatory projects to crossfunctional teams and senior leadership
  • Maintain understanding and working knowledge of regulatory requirements applicable to CMC regulatory in
    applicable geographies
  • Develop understanding and working knowledge of Collegium’s manufacturing and analytical procedures and method
    validations
  • Review technical documents including testing protocols, technical reports, and CMO procedures and specifications
    from a CMC regulatory perspective
  • Acts as regulatory liaison and single point of contact in meetings and interact with members of the project team and
    sub-teams for assigned projects.
  • Prepare and review change implementation plans (change control) to manufacturing processes, laboratory methods
    and specifications to ensure compliance with FDA guidelines and to maintain adequate control and flexibility for the
    life cycle management of the product.
  • Uphold and consistently demonstrate Collegium’s Core Values
  • Role accountable for delivery of team goals
  • Communicate clearly with explanations and clarifying questions.
  • Implement continuous improvements and solves routine problems.
  • Develop skills within a narrow technical domain, some independence.
  • Coach others and in some cases may have direct reports

Qualifications

  • Bachelor’s degree required; Bachelor’s of Science preferred.
  • 6-8 years of related experience required; Minimum of 3 years in CMC Regulatory Affairs in Pharmaceutical or Life
    Sciences required
  • Experience with the management of regulatory submissions
  • Solid regulatory authoring/writing experience
  • Solid knowledge and application of FDA regulations and cGMP requirements
  • Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required

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