Sobre este puesto de Manager, Regulatory Affairs en Collegium Pharmaceutical
Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications.
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
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.
