Sr Regulatory Affairs Associate

Sr Regulatory Affairs Associate

The Sr. Regulatory Affairs Associate will perform diversified duties under general direction in order to meet domestic and international product submission and/or registration requirements.  Participate as active and engaged members of new product development teams.  Conduct meetings with R&D, QE, Marketing and Clinical to assess/assign critical elements for new product submissions to FDA and international authorities (including, but not limited to performance testing, preclinical testing and clinical testing).  Determine product submission requirements, develop regulatory strategy, and apprise management to ensure adequate data is developed for product submission.  Prepare product registration dossiers, e.g., 510(k) submissions, PMAs, IDEs, international dossiers. Accountable for ensuring timely and accurate submissions in compliance with appropriate standards and content requirements.  Accountable for identification of submission risks and development of alternate courses of action in anticipation of regulator’s responses through scenario planning and contingency plans.  Interface with FDA and applicable EU Notified Body regarding regulatory submission strategies and approvals.  Correspond with international company RA and distributors regarding requirements, dossiers and registration status.  Obtain product export certificates.  Review and approve product labeling ensuring compliance with current regulations.  Further responsibilities include reviewing industry newsletters and regulatory journals in order to monitor registration/regulatory requirements.  Attending product registration conferences and seminars.  Performing other related duties as assigned or warranted.  A Bachelor of Science degree in physical sciences is required, a Master’s degree preferred.  A minimum of five years relevant experience is required.  A broad knowledge of biology, chemistry or related field is necessary.  Excellent verbal and written communication skills and strong organizational skills is also required.

Please refer to job code SD6807 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Branford, CT
County:	New Haven County
ZIP Code:	06405
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856