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Sr. Manager Global Regulatory Affairs

Company Name:
The Suburban Group, Inc.
ABOUT THE COMPANY
This client is part of a global pharmaceutical and chemical group. They strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise
THE ROLE YOU WILL PLAY
This client has engaged us to find a Sr. Manager of Regulatory Affairs to assist the Global regulatory lead and/or the Regional lead in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical trials, marketing applications or other related regulatory submissions (Orphan designation and annual report, pediatric plans, DSUR, PBRER.
You will demonstrate your expertise in managing the regulatory submission process through to approval, including management and coordination of the preparation of all regulatory documentation at different milestones.
You will show top leadership why you are a recognized expert in managing regulatory agency interactions, document preparation, etc.
You will flex your 'regulatory muscles' by contributing to the development and evaluation of strategies for projects
You will affect the bottom line by reviewing and providing regulatory comments to quality, safety, and efficacy or labeling related documents to be including in regulatory submissions.

BACKGROUND PROFILE
You will have a minimum of a bachelor's degree in the Life Sciences or related degree with 3+ years of Regulatory Affairs experience. Possessing a higher degree (Ph.D., MS, etc) will really make you stand out
You will be able to show your expertise in the preparation and submission ofa full submission or large variation/supplement in at least one ICH region through to authorization
You will be able to demonstrate your experience in working with regulatory agencies and the preparation of documentation to support interactions
You will show your hands on knowledge of IND/CTA requirements
Having eCTD experience will have you stand out above others

This client offers exceptional compensation including base, bonus, stock options, and an excellent benefits package.
Candidates should submit their CV along with salary requirements ASAP. This client will offer relocation for the right candidate, sorry, they cannot accept candidates who need sponsorship at this time.
Mark Carlson, CPC
Sr. Vice President & Executive Recruiter
(774) 551-5920

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