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Manager, Regulatory Affairs (Vaccines)

Company:
Headhunters, LLC
Location:
Gaithersburg, Maryland, United States
Salary:
DOE
Posted:
December 03, 2018

Description:

Headhunters, LLC's client is seeking a Regulatory Affairs Manager to support regulatory activities for our client's Vaccine Business Unit and serve as the regulatory representative on assigned Product Team(s). He/she will work with the Senior Managers and functional line management to develop regulatory strategies and manage regulatory submission activities for the assigned product. The Regulatory Affairs Manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions.

Responsibilities

-Manage regulatory activities for the assigned area to support Vaccine Business Unit

-Support the development of regulatory strategies for assigned vaccine products

-Represent Regulatory Affairs on assigned product/ project teams and ensure timely communication of regulatory strategy and plans to team members and line management

-Plan and coordinate the preparation of regulatory submissions including meetings with health authorities, INDs, Annual Reports, BLAs and BLA supplements, and routine correspondence

-Provide critical review of all documentation supporting regulatory applications

-Provide gap analysis based on regulatory requirement and present options to mitigate risk

-Support activities to prepare for meetings and teleconferences with regulatory agencies

-Provide regulatory assessment for deviations, change controls and complete associated regulatory activities to ensure license compliance

-Interact with company partners and consultants for various regulatory matters as needed

-Track and ensure that regulatory commitments are met

-Respond timely to requests for information from internal customers.

-Participate as needed in Inspections to provide details on Regulatory Submissions and submission history.

Education, Experience & Skills

-Bachelor’s degree in a life sciences or related discipline required.

-5+ years of industry experience in Regulatory Affairs.

-Must have experience interacting with FDA and other regulatory agencies.

-Must have regulatory experience in vaccines and/ or biological product in development or post approval setting.

Please email your resume and cover letter to Meredith: Meredith@Headhuntersllc.org