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Director, Regulatory Affairs CMC

Schaumburg, IL

Posted: 01/20/2021 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2728

Job Description


Responsible for leading the CMC regulatory function, the Director, Regulatory CMC will collaborate cross- functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products, this position will lead the preparation and filing of regulatory CMC submissions and manage the interactions with all Health Authorities for CMC topics. This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.

Responsibilities:
  • Plans, manages, and executes CMC regulatory activities for assets in various phases of development.
  • Responsible for the coordination, authorship, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submission and marketing applications to FDA and international regulatory authorities), which support clinical programs, CMC and quality.
  • Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
  • Develops and implements CMC Regulatory strategies for assigned projects and provides advice and strategic guidance to development teams.
  • Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.
  • Serves as the Regulatory lead in Health Authority meetings and leads preparation of CMC activities for meetings with Health Authorities.
  • Interacts directly and indirectly with FDA and international Health Authorities, as necessary.
  • Ensures line management and key stakeholders are apprised of ongoing developments.
  • Maintains current knowledge of relevant US and international guidances, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.

Requirements / Qualifications:
  • BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
  • 8 to 10 years pharmaceutical industry experience with a minimum of 5 years in regulatory affairs CMC or a related pharmaceutical development field. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems, highly desirable.
  • Established working knowledge of pharmaceutical drug development and related global CMC regulations/guidelines.
  • Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
  • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and/or product development meetings.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Detail oriented and well organized.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

Meet Your Recruiter

Aaron Goldman
Principal Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past nine years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!

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