Senior Manager, Regulatory Affairs

  • Location:Cambridge, MA
  • Department:Regulatory Affairs
  • Type:Full Time
  • Min. Experience:Manager/Supervisor

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

SUMMARY:

We are seeking an organized, independent, and self-motivated Regulatory Affairs Senior Manager who will provide support to the regulatory affairs department with oncology products in early- and late-stage development. The Sr. Manager will assist in the development and implementation of regulatory strategy for multiple projects. Working in a team environment, the Sr. Manager is responsible for planning and coordinating multiple aspects of regulatory submissions necessary to support clinical trials and product registration.

 

RESPONSIBILITIES:

  • Provides input to regulatory submission strategy, prepares regulatory submission documents, and reviews regulatory submissions for completeness and quality in accordance with regulatory agency requirements, standards, and corporate practices
  • Identifies and compiles materials required in U.S. and/or ex-US regulatory submissions (INDs/ CTAs and marketing applications) including technical writing and tracking timelines
  • Responsible for regulatory review of documents, as required
  • Represents the regulatory affairs function in study and project teams to provide regulatory support and advice
  • Provides support for regulatory interactions, including meetings and teleconferences
  • Shows good judgment to determine when to escalate problems to his/her superior
  • Analyzes the global regulatory requirements and environment, and provides assessments of the impact of new and changing regulations
  • Drafts and/or modifies applicable SOPs and/or other written practices relating to the regulatory affairs function

 

EDUCATION AND EXPERIENCE: 

  • Bachelor’s degree in life sciences or a related field required. Advanced degree preferred
  • 2-5 years’ experience in the pharmaceutical/biotechnology industry within Regulatory Affairs function with meaningful oncology experience
  • Experience with regulatory submissions including INDs, CTAs, and marketing applications
  • Strong knowledge of applicable regulatory requirements including but not limited to GXPs
  • Highly organized, independent, and self-motivated with ability to multi-task
  • Very strong written, verbal, and interpersonal communication skills
  • Ability to work independently and in close collaboration in a cross-functional team setting