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 Vice President, Regulatory Affairs will be responsible for providing regulatory leadership for our organization and products, which includes leading the regulatory team. As a leader, role model, and mentor within the company, he/she will ensure all regulatory deliverables across programs are completed according to timelines, budget, operational procedures, regulations, International Council for Harmonisation-Good Clinical Practice (ICH-GCP) guidelines, and quality standards. He/she will also be required to be “hands-on” as we celebrate teamwork in execution of our objectives and goals across our company.

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 the regulatory organization and activities within the Regulatory Affairs team. As such, he/she will:
• • Help establish and support Regulatory strategies and tactical plans to meet the needs of Collegium; defining, monitoring, managing, and executing to achieve short-term and long-term objectives.
  • Lead and develop the Regulatory team to achieve the functional objectives.
  • Ensure all Regulatory team deliverables support the team objectives and are completed according to defined timelines, budget, policies, regulations, procedures, and any additional guidelines, quality, or any other applicable standards.
  • Provide expertise, guidance and serve as subject matter expert for all Regulatory matters.

• Actively communicate and collaborate with other functional areas and external partners to meet the needs of the business; provide guidance in the development of compliant sales training, advertising, and detail literature, advise Medical on regulatory issues and impact, support Pharmacovigilance (PV) by finalizing aggregate reports in FDA-required eCTD format, assist with other PV submissions, as needed, and provide input to Business Development on new product acquisitions and product out-licensing candidates.
• Effectively communicate with the Regulatory Affairs team and peers, and/or executive committee.
• People management is required and will likely include employee interviewing and hiring, employee engagement, coaching, talent reviews, mid-year check ins, annual performance reviews, objective, and goal setting, and working with staff on individual development plans (IDPs). The expected outcome would be promoting a culture of innovation, constructive challenge, team spirit, and accountability.
• Manage financials, consulting agreements, and contracts within the Regulatory Affairs team. As such, this individual will be a steward of company resources and will ensure on-time and efficient projects and programs.
• As the primary owner, this individual will work closely with other Medical sub-functions as appropriate to:
• • Provide (and/or oversee) regulatory review support for the Medical Review Committee (MRC).
  • Lead other priorities such as Risk Evaluation and Mitigation Strategies (REMS) program and participation.
  • Ensure that the Regulatory Affairs team and projects are compliant with federal regulations and Standard Operating Procedures (SOPs).
  • Establish and oversee the development, documentation, implementation of and compliance with Regulatory Affairs systems and processes and “best practices.”
  • Lead the development of investigator brochures and regulatory submissions.
  • Analyze and make recommendations for improving regulations and guidelines and communicate with US, and/or international regulatory agencies (as appropriate).
  • Review and approve regulatory files [i.e., New Drug Applications (NDAs), supplemental NDAs (sNDAs), etc.] for approved products; manage post-market surveillance requirements for commercial products by

assessing regulatory categorization of adverse events reported during use in the population and assist Pharmacovigilance in the preparation and filing of expedited safety and periodic safety reports to FDA, as necessary.

• Ensure accurate, current, and timely regulatory training internally and externally as applicable.
• Though not the primary owner, this individual will work closely with Medical’s sub-functions as appropriate to:
• • Support the development of medical/scientific communication plans, medical symposia, congress planning, and publication planning, as necessary.
  • Assist in the development of and medical responses both verbally and written (i.e., MIRFs, publications, etc.).
  • Assist as needed with the successful management of medical advisory boards.
  • Assist PV with aggregate report submissions in eCTD format as required by FDA
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  • Represent the Company and the Regulatory Affairs team in interactions (both in writing and in person) with Health Authorities (i.e., HHS, FDA, CMC, DEA, etc.), CROs, Investigator Meetings, Advisory Boards, and to all stakeholders.Create an environment that motivates all employees across the organization to deliver innovative programs and empower others in order that they may execute accordingly to meet stakeholder needs.
  • Uphold and consistently demonstrate Collegium’s Core Values.

• Advanced degree in medical science (PhD, PharmD, MD, DO, or ScD) required.
• Minimum of 5-7 years of Industry (Pharmaceutical or Life Science) experience required; minimum of 4 years specifically in Regulatory Affairs. Knowledge of Commercial support, CMC, and a track record of having worked on teams towards successful submissions and license approvals with CDER or CBER required.
• A comprehensive knowledge of Food and Drug Administration (FDA) regulations and International Council for Harmonisation (ICH) guidelines required.
• Knowledge of CMC Regulatory activities would be a plus.
• Demonstrated experience leading a team to deliver against objectives.
• Demonstrated leadership capabilities including hiring, building, and leading a team. This includes assisting with developing team and individual objectives, providing employee feedback, performance management, and employee development.
• Experience collaborating with diverse stakeholders and building strong, collaborative relationships required.
• Proven ability to work effectively in a cross-functional and collaborative environment.