Details for the position are as follows:
As a Manager in Global Regulatory Sciences team, this role will have responsibility supporting and implementing the development of global regulatory strategies to advance and maintain Blueprint’s mast cell disease portfolio. Reporting to the Director of Global Regulatory Sciences, this individual will primarily provide regulatory support of both an operational and strategic nature to the Global Regulatory Lead(s) and cross-functional teams responsible for the development, registration and maintenance of Blueprint compounds in mast cell disease indications. The individual will also ensure effective communication and constructive working relationships with external collaborators and regulatory authorities.
- 5-month contract to start with the possibility of extension or conversion to perm depending on performance and budget
- Rate: $60-75 an hour
- Location: Cambridge, MA -Hybrid
As a Manager in Global Regulatory Sciences team, this role will have responsibility supporting and implementing the development of global regulatory strategies to advance and maintain Blueprint’s mast cell disease portfolio. Reporting to the Director of Global Regulatory Sciences, this individual will primarily provide regulatory support of both an operational and strategic nature to the Global Regulatory Lead(s) and cross-functional teams responsible for the development, registration and maintenance of Blueprint compounds in mast cell disease indications. The individual will also ensure effective communication and constructive working relationships with external collaborators and regulatory authorities.
- Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program
- Responsible for relevant submissions for assigned program(s).
- Represent the Global Regulatory Sciences function on cross functional teams
- Support line manager in developing and implementing long and short-term product regulatory strategies/plans
- Plan for and lead preparation efforts for health authority meetings
- Provide guidance to external vendors and consultants as needed
- Bachelor’s degree in scientific discipline; advanced scientific related degree a plus
- Minimum of 4 years of direct work regulatory affairs experience
- Experience in oncology/rare diseases drug development a plus