At Collegium Pharmaceutical, we are building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a portfolio of meaningfully differentiated medications to treat serious medical conditions, including moderate-to-severe pain and acute migraine.

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.

Persons applying for employment with Collegium Pharmaceutical on and after August 1, 2021, who are offered a position are expected to be able to provide proof of vaccination against COVID-19 prior to their start date as permitted under state law, unless they seek and are approved for an exemption by Collegium as a reasonable accommodation based on bona fide religious or medical grounds.

• 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

• 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