Manager, Regulatory Affairs

. Responsibilities: - Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
-Responsible for submitting moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories.
-Acts as project team representative for specified products and provides strategic regulatory advice as appropriate.
-Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information to project teams and senior management in a timely manner.
-May contribute to training of staff under direction of Senior Regulatory Affairs Professional.
-May initiate local process improvements and contribute to local and / or global process improvements, which have a moderate impact on the Regulatory Affairs function or other departments.
Plans, schedules and arranges own activities and may direct others in accomplishing objectives.

Requirements:

-Typically requires a BA degree in relevant discipline and minimum 8 years of relevant experience in Regulatory Affairs or related field.
-An advanced degree is desirable.
-Previous supervisory experience is desirable.
-Direct experience working with Regulatory Authorities in assigned territories is desirable.
-Excellent organization skills and ability to work on a number of projects with tight timelines is required.
-Excellent verbal and written communication skills and interpersonal skills are required.
-Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
-Must be capable of developing and implementing regulatory strategy and of managing negotiations with Regulatory Authorities.
-Must be capable of leading a small team in preparation of submissions.

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