Sr. Manager/Associate Director, Regulatory Strategy

Posted on Feb 8, 2019 by Ascent

Cambridge, MA 02142
Senior Appointments
Immediate Start
Annual Salary
Full-Time
Sr. Manager/Associate Director, Regulatory Strategy

The Position:

Foster drug development by facilitating identification and resolution of scientific and regulatory issues with the regulatory agencies. Direct the implementation of regulatory strategy for assigned products. Collaborate with other colleagues in Regulatory Affairs at on preparation of internal teams for FDA and EMA meetings and interactions. Interact successfully with all levels of management. Direct the preparation and submission of INDs, CTAs, NDAs, reports and correspondences to the appropriate regulatory agencies for assigned projects.

Primary responsibilities include:
  • Contribute to proactively formulating regulatory strategies that provide a streamlined development and approval time line while accurately interpreting and reflecting regulatory and Corporate guidelines.
  • .
  • Assist with planning, preparation for and conduct of meetings with Regulatory agencies for all assigned products. Initiate and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
  • Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
  • Guide project teams to implement appropriate regulatory strategies.
  • Supervise and coordinate all regulatory activities required for submissions to regulatory agencies for assigned products.
Education and Skills Requirements:
  • Demonstrated knowledge of drug development process is essential. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
  • Experience with preparing IND submissions and briefing packages for regulatory meetings essential.
  • Experience with successful NDA, sNDA and/or BLA filing preferred.
  • Prior experience working with EMA preferred.
  • Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 5 years regulatory experience. Demonstrates personal leadership, with a natural ability to bring divergent views together, agree common objectives and engenders enthusiasm even in challenging circumstances.
Company Description:

About Ascent:

Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.

If you are ready to propel your career to new heights… read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Reference: 636940596

Similar Jobs

Director, Global Regulatory Affairs - Neurology

Cambridge, MA

Ipsen Biopharmaceuticals, Inc.

Sr. Research Associate - Proteomics

Cambridge, MA

Celgene

Senior Director, US Commercial Regulatory Affairs

Cambridge, MA

Ipsen Biopharmaceuticals, Inc.

Associate Director, Data Reporting Lead

Cambridge, MA

Ipsen Biopharmaceuticals, Inc.