Senior Manager, Regulatory Affairs Advertising and PromotionStoughton, MA
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 severe and persistent pain and ADHD.
POSITION OVERVIEW The Senior Manager, Regulatory Affairs Advertising and Promotion will be responsible for providing sound regulatory advice related to promotional and medical communication of information related to designated Collegium products in the neurology disease area with a secondary focus on pain. The Senior Manager partners with cross-functional colleagues in Marketing, Market Access, Commercial Operations, Regulatory, Medical Affairs, Sales, Legal, and Compliance in support of commercial business initiatives and review of external communication materials. The Senior Manager develops and maintains positive working relationships within and across departments in relation to promotional issues.
RESPONSIBILITIES Provide oversight and review of product and disease state education materials for consistency with approved labeling and alignment with applicable FDA regulations and guidance. Seek guidance from Senior Regulatory staff to support the business and alternative solutions to challenges in order to achieve desired outcomes.Member of multi-disciplinary teams such as Material Review Committee (MRC), MRC Working Group, MRC Reviewers Group, and reporting to Regulatory Affairs.Maintain up-to-date knowledge of FDA laws, regulations, and guidance, as well as the compliance environment as it relates to advertising and promotion of pharmaceutical products. Advise appropriate departments within the company of these requirements.Provide training in FDA regulations for advertising and promotion to employees and agents of Collegium.Build and maintain strong relationships with internal stakeholders including Marketing, Market Access, Commercial Operations, Regulatory, Medical Affairs, Sales, Legal, and Compliance.Serve as primary contact for OPDP for assigned products and ensure timely and accurate submission of product promotional materials to FDA under Form FDA-2253.Author regulatory documents as needed including cover letters, briefing documents, annual reports, and labeling including package inserts and artwork, under minimal supervision and serve as in-house regulatory expert to internal and external stakeholders.Uphold and consistently demonstrate Collegium's Core Values.Role accountable for the delivery of team goals.Communicate clearly with explanations and clarifying questions.Implement continuous improvements and solve routine problems independently.Coach others and, in some cases, may have direct reports.REQUIRED LEADERSHIP BEHAVIORS HeadKnow our BusinessThink CriticallyDecideExecuteHeartCollaborateDevelopCommunicateEmbrace AuthenticityBe DisruptiveEvolveQUALIFICATIONS Bachelor's degree required in a scientific field such as biology or chemistry; master's degree and PharmD strongly preferred.Minimum 6 years of related experience in Regulatory Affairs in the Pharmaceutical or Life Sciences; Minimum of 3 years in a commercial organization.Excellent written and oral communication skills creating regulatory submissions including cover letters and content documents.Experience with document management systems and electronic publishing required.Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required.Pay Range: $160,000 - $176,000 USD
Collegium is an equal opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment-related decisions upon valid job-related factors, without regard to age, national origin, citizenship status, ancestry, race, color, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information, or any other status protected by applicable federal, state, or local law. This policy applies to hiring, training, promotion, compensation, disciplinary measures, access to facilities and programs, and all other personnel actions and conditions of employment.
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