Collegium Pharmaceutical Inc (COLL)

[floblu14]

28 new career positions listed now after restructuring loss of approximately 50 positions.

Getting ready for the acquisition of BDSI at end of this month.

Among them is this post -

Senior Manager of Regulatory Affairs

POSITION OVERVIEW

The Senior Manager, Regulatory Affairs will play a leadership role in providing 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).

Responsibilities

Lead international 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, Health Canada, and the EMA

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

https://careers-collegiumpharma.icims.com/jobs/1513/senior-manager-of-regulatory-affairs/job