Search Jobs

Your NEXT GREAT OPPORTUNITY is within reach!

Associate Director, Regulatory Strategy

Cambridge, MA

Posted: 09/19/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2417

Our client is looking to add an Associate Director of Regulatory Strategy to their team on a permanent basis. The person in this role will foster drug development by facilitating identification and resolution of scientific and regulatory issues with global regulatory agencies. S/he will also direct the implementation of the regulatory strategy for assigned products, and collaborate with other Regulatory Affairs colleagues on preparation of internal teams for FDA and EMA meetings and interactions. This person will interact successfully with all levels of management, and will direct the preparation and submission of INDs, CTAs, NDAs, reports and correspondences to the appropriate global regulatory agencies for assigned projects.

Primary Responsibilities Include:
  • Assume the role of Global Regulatory Lead (GRL) for assigned products.
  • 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.

Requirements / Qualifications:
  • 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.
  • Candidates must be authorized to work in the U.S.

Sam Williams
Clinical Recruiter

Sam brings great enthusiasm and a passion for the life sciences to his role as Clinical Recruiter for The Steely Group. Outgoing and driven with a great sense of humor, Sam connects easily with people and prides himself on his ability to cultivate lasting relationships. He values honesty, communication and empathy in a candidate, and has a genuine interest in helping others achieve their professional goals.

Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.