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Regulatory CMC Lead

Company: Shire Pharmaceuticals
Location: Lexington
Posted on: September 22, 2018

Job Description:

The Associate Director of CMC Regulatory Affairs will serve as the global product leader for CMC regulatory strategy of one or more biological and/or small molecule products. This will include formulating and implementing global CMC regulatory strategies for the development of protein therapies, lead CMC regulatory activities for assigned projects in line with global requirements. Primary role includes:



  • Serve as a liaison between the regulatory authorities and the company on CMC issues
  • Provide CMC RA leadership within RA and on cross-functional CMC teams
  • Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations





    • Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls (10%)
    • Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities, for commercial and/or development programs. (50%)
    • Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)
    • Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)


      • Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)

        Education & Experience Requirements

        Include educational requirements or equivalency, required years and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred.

        • B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
        • At least 7 years of drug development/pharmaceutical industry experience (or equivalent) including significant strategic experience (5+ years) in CMC regulatory affairs (or equivalent) with a small molecule and/or biologics background.
        • Demonstrated leadership in regulatory strategy and experience in regulatory interactions

          Key Skills and Competencies

          Describe critical skills needed to successfully perform job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

          • Excellent interpersonal, communication, analytical and managerial skills.
          • Demonstrated experience with global development, registration and post-approval submissions
          • Ability to work successfully with cross-functional teams and influence appropriate plans and actions.
          • Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
          • Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
          • Ability to work independently, take initiative and complete tasks to deadlines.


            Other Job ComponentsComplexity and Problem Solving

            Describe the decisions made by the incumbents on a regular basis. Include decisions within the incumbents authority to make as well as those decisions that must be referred to a higher level.

            Internal and External Contacts

            List contacts this job advises, consults and coordinates with on a regular basis. Describe to whom this job is accountable. Indicate each Contact Category (Internal, Vendor, Customer, or Other) and provide examples.

            Other Requirements

            List any other job requirements, including domestic travel, international travel, drivers license, physical abilities required, etc.

            Keywords: Shire Pharmaceuticals, Taunton , Regulatory CMC Lead, Other , Lexington, Massachusetts

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