Posted to MedZilla on 8/20/2017


ProClinical

United States, CMC Regulatory Consultant RA_HC_13180-MZ


 
 

ProClinical is seeking a Senior Scientific & Regulatory Manager for a global, commercial stage biotechnology company based in Massachusetts. As a Senior Scientific & Regulatory Manager, you will be responsible for producing and editing CMC regulatory documents for submission to regulatory agencies located world-wide with emphasis on the FDA and EMA. Must have the ability to summarize technical study reports and subject matter expert provided data in a manner that supports the strategic intent of the regulatory submission. You will provide regulatory and research expertise for several projects and ensure successful preparation of high-quality submission-ready documents through effective implementation of team-based writing processes. You will work closely with all CMC related SMEs (Manufacturing of drug substance and drug product, labelling, process development and quality control). As a partner to subject matter experts ensure accurate and timely completion/delivery of information and review of regulatory submissions.

The ideal candidate has well-developed and demonstrable writing skills, understands strategic communications, and has the ability to "simplify the complex". Strategic/critical thinking skills, as well as initiative, are a must for this role! Additional skills needed include a sense of urgency (milestone/timeline driven) and the ability to ask questions and probe further.

Support all CMC regulatory filing activities for various pre-INDs, INDs, IMPDs, CTAs and NDAs/MAAs and track regulatory commitments.

Job Responsibilities:

  • Manage timelines in cooperation with project management, Operations, SMEs and Tarrytown Regulatory Operations (RegOps) to ensure on time regulatory submissions.
  • Assist with the planning, scientific writing and perform critical reviews of preINDs, INDs, IMPDs. NDAs, MAAs, annual reports, amendments, supplements to ensure a high quality regulatory submission and approval
  • Ensure that all regulatory submissions are of highest regulatory standards.
  • Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and NDAs/MAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements.
  • Support establishing, managing and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
  • Support Ops by providing CMC related guidances so that their short-term and long-term goals are achieved on time and with highest quality.
  • Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.

Skills and Requirements:

  • Requires a Ph.D. or M.S. degree in a science related discipline
  • Minimum of 10 years pharmaceutical industry experience and 3-6 years of relevant CMC biotech/pharmaceutical industry experience.
  • Strong CMC technical writing skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hannah Cihlar on +1 267 983 0133 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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