Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday.
POSITION OVERVIEW The Manager, Regulatory Affairs will play a key role in providing Regulatory support for Collegium's marketed products and development programs. They will work in a highly cross-functional manner with internal stakeholders including Medical, Commercial, Legal and Compliance, and Technical Operations to file and maintain the applications for Collegium's marketed products and development programs in compliance with applicable regulations.
RESPONSIBILITIES - Prepare Investigational New Drug (IND) and New Drug Application (NDA) submissions to the FDA to support development programs and Collegium marketed products
- Ensure regulatory submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and other applicable regulatory requirements
- Collaborate with internal stakeholders in Commercial, Medical, Technical Operations, and other business partners to plan, compile, and affect submission of required information to FDA and other relevant Health Authorities
- Manage and drive collection and coordination of all material necessary for regulatory filing
- Serve as primary interface with regulatory publisher for electronic submissions via FDA's submission gateway
- Prepare IND Annual Reports, NDA Annual Reports and Periodic Adverse Drug Experience Reports
- Oversee regular maintenance of regulatory files and document systems
- Manage labeling for approved and investigational products, including U.S. prescribing information, clinical trial labeling, and packaging components, while coordinating cross-functional reviews to ensure regulatory compliance, accuracy, and consistency throughout the product lifecycle.
- Uphold and consistently demonstrate Collegium's Core Values
- Be accountable for delivery of team goals
- Communicate clearly with explanations and clarifying questions
- Implement continuous improvements and solve routine problems
- Develop skills within a narrow technical domain, some independence
- Coach others and in some cases may have direct reports
REQUIRED LEADERSHIP BEHAVIORS At Collegium, how we achieve results is just as important as what we achieve. Our Leadership Behaviors define how we work, collaborate, and succeed as we continue to evolve as an organization.
We group these behaviors into three pillars:
- HEAD
- Think Entrepreneurially
- Take Decisive Action
- Drive Results
- HEART
- Communicate Effectively
- Enable High Performance
- Collaborate with Purpose
- GUTS
- Take Smart Risks
- Be Tenacious About Change
- Compete to Win
Successful candidates will demonstrate these behaviors through their ability to challenge the status quo, build strong relationships, drive results, embrace change, and contribute to a high-performance culture.
QUALIFICATIONS- Bachelor's degree required, Master's degree strongly preferred
- 4-6 years of related experience in Pharmaceutical or Life Sciences required
- Strong knowledge of applicable regulations
- Experience with document management systems and electronic publishing required
- Strong verbal and written communications skills
- Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required
Pay Range
$132,219-$158,400 USD
