Collegium Pharmaceutical

Regulatory Affairs Manager

Job Locations US-MA-Stoughton
Posted Date 1 month ago(4/13/2022 3:05 PM)
ID
2022-1513
# of Openings
1
Category
Regulatory Affairs & Quality Assurance

Overview

Collegium Pharmaceutical is building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Our portfolio compels us to step into the pain market at a time when others have opted to step out. We recognize the importance of earning the trust of key stakeholders every day. We are focused on building the Collegium of tomorrow and we remain focused on making a positive difference in the lives of people living with serious medical conditions  and our communities.


 


POSITION OVERVIEW


 


The Manager, Regulatory Affairs will provide Regulatory support for Collegium’s marketed products and development programs.  Manage regulatory input into project tams and provide regulatory strategies to ensure appropriate implementation of key business initiatives. This role will be the single point of contact between the Company and Health Authorities such as the Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA). They will work in a highly cross-functional manner with internal stakeholders including Clinical, Commercial, Technical Operations, and Quality Assurance to file and maintain the applications for Collegium’s marketed products and development programs in compliance with applicable regulations.

Responsibilities


  • Lead product registration and licensing Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing, or records keeping and ensure that they are communicated through company policies and procedures

  • Influence and contribute to the short and long term Regulatory planning of new product opportunities

  • Serve as the primary contact between Collegium and Regulatory Authorities such as the FDA

  • Own Investigational New Drug (IND) and New Drug Application (NDA) submissions to the FDA to support development programs and Collegium marketed products

  • Collaborate with internal stakeholders in Commercial, Quality Assurance, Technical Operations, and other business partners to plan, compile, and affect submission of required information to FDA and other relevant Health Authorities

  • Lead and drive collection and coordination of all material necessary for regulatory filing

  • Own the relationship with external vendors for regulatory submissions

  • Manage and secure all advertising and promotional pieces intended for FDA submission

  • Own and prepare IND Annual Reports, NDA Annual Reports and Periodic Adverse Drug Experience Reports

  • Oversee regular maintenance of regulatory files and document systems

Qualifications


  • Bachelor’s degree required, Master’s degree preferred

  • 2-7 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

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