Job responsibilities:

• Develop regulatory strategies integrated with cross functional project teams and external stakeholders to facilitate timely subscriptions and approvals for post market regulatory submissions.
• 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.
• 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.
• 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.
• Provide Regulatory Expertise and serve as internal consultant on relevant US regulations and guidelines, current regulatory environment, and regulatory precedent.
• 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.
• 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 precise or clear regulatory guidance available from FDA.
• Write and revise regulatory affairs standard operating procedures (SOPs), policies, and work instructions to ensure compliance and consistency for department processes.
• Plan regulatory submissions to maintain INDs, NDAs, advertising and promotional pieces, and to address annual and periodic regulatory commitments.
• Train and mentor junior regulatory affairs staff on the processes and systems used to manage all aspects of the department deliverables. 

Requirements:

• Masters Degree in Regulatory Affairs

Applicants are to send Resumes to: Director, Talent Acquisition, Nick Zweig at hr@collegiumpharma.com