Senior Manager, Regulatory Affairs Advertising and Promotion

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.

Hybrid : Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.

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 neurology disease area with 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.

Seeks 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.
• Communicates clearly with explanations and clarifying questions.
• Implements continuous improvements and solves routine problems independently.
• Coach others and in some cases may have direct reports.

REQUIRED LEADERSHIP BEHAVIORS

Leadership Behaviors are a core set of behaviors that vary based on the Level in the organization. We have categorized these under Head, Heart, and Guts.

• Head
• Know our Business
• Think Critically
• Decide
• Execute
• Heart
• Collaborate
• Develop
• Communicate
• Embrace Authenticity
• Guts
• Be Disruptive
• Innovate
• Evolve
• Be Tenacious

QUALIFICATIONS

• 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.

By this policy, Collegium seeks to ensure that all employees have the opportunity to make their maximum contribution to Collegium and to their own career goals.

This policy provides for an equal employment opportunity program that will simultaneously serve the requirements of society, the law, sound business practices and individual dignity.

If you have questions or concerns about equal employment opportunities in the workplace, you are encouraged to bring these issues to the attention of the Head of Human Resources.

We will not allow any form of retaliation against employees who raise issues of equal employment opportunity. To ensure our workplace is free of artificial barriers, violation of this policy may result in disciplinary action, up to and including termination.

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