Job Duties:

1. Develop regulatory strategies integrated with cross-functional project teams and external stakeholders to facilitate timely submissions and approvals for post market regulatory submissions.
2. Author regulatory documents including cover letters, briefing documents, annual reports and labeling including package inserts and artwork, under minimal supervision and serve as inhouse regulatory expert to internal and external stakeholders.
3. Manage the label management process for all Collegium portfolio products including managing the approval of label changes and implementing revised labels and artwork with labeling vendors.
4. Review and approve change controls to determine the level of change and consequent submission requirements, assess potential impact on business objectives, and communicate impact accordingly to stakeholders in CMC, Manufacturing, and Technical Operations.
5. Provide regulatory expertise and serve as internal consultant on relevant US regulations and guidelines, current regulatory environment, and regulatory precedent.
6. Develop and maintain relationships with the FDA and lead the preparation of agency interactions as the main liaison between the company and the FDA Project Manager.
7. Handle urgent matters that arise from FDA information requests, offer regulatory counsel to stakeholders in Clinical, CMC and Medical, and reach well-thought-out strategies to address regulatory matters for which there may not be precise or clear regulatory guidance available from FDA.
8. Write and revise regulatory affairs standard operating procedures (SOPs), policies, and work instructions to ensure compliance and consistency for department processes.
9. Plan regulatory submissions to maintain INDs, NDAs, advertising and promotional pieces, and to address annual and periodic regulatory commitments.
10. Train and mentor junior regulatory affairs staff on the processes and systems used to manage all aspects of the department deliverables.

Employer requires: Master’s Degree in Regulatory Affairs.

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.