Post Approval CMC Regulatory Specialist
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Post Approval CMC Regulatory Specialist
Ref No.: 18-01118
Location: Rahway, New Jersey
Position Type:Contract
Start Date: 08/09/2018
POST APPROVAL CMC REGULATORY SPECIALIST
WEST POINT, PA / RAHWAY, NJ


Required Skills:
  • Minimum BS, Chemistry/Biochemistry, Chemical Engineering, Pharmacy, Biology or related science.
  • A minimum of 5 years in the Pharmaceutical Industry with post approval CMC regulatory strategy, regulatory submission and related experience.
  • A strong pharmaceutical background with in-depth knowledge of CMC regulations and guidance, and exposure to developing global regulatory strategies for post approval changes is required.
  • Strong post approval authoring experience.
  • Experience creating content, not just working off of templates.
  • The candidate will have demonstrated ability to be a strong team member both within and outside the department with the ability to drive projects to completion and provide innovative new solutions to changing deliverables.
  • This position requires good organizational, communication, electronic systems and project management skills.
  • The candidate will be required to implement the CMC submission activities (planning, preparing, review, and submission), and to ensure the accuracy and clarity of the submissions.

Project Description:
  • The candidate will be responsible for preparing CMC regulatory submissions for client marketed drug products.
  • The position will have responsibility for executing regulatory strategy for anticipated analytical, manufacturing and packaging changes, compilation of post approval regulatory submissions including annual reports, renewals, supplemental applications, variations and other maintenance dossiers and coordination of responses to health authority questions and comments within agreed upon timelines.
  • Strong interaction with Technical Operations personnel at manufacturing sites and other key partners both internal and external to the company.
  • This position requires the ability to independently manage multiple projects in alignment with company objectives.

This 5+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.com

ALPHA'S REQUIREMENT #18-01118
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE