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Manager to AD, Regulatory CMC

Cambridge, MA 02139

Posted: 08/20/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2409

Reporting to the head of Regulatory CMC, you  will support all CMC regulatory affairs activities for the company’ s products. You will drive the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, CTAs, and prepare development plans for original marketing applications (BLAs/MAAs). You will provide regulatory guidance and oversight and improve internal standards and systems.

  • Independently define CMC content requirements (data and documentation) for regulatory submissions in conformance with global regulatory requirements and company standards.
  • Drive adherence to CMC regulatory guidelines relevant for the development of biologics and combination products in close collaboration with global development teams, including Technical Operations and Quality, and with relevant external parties including contract manufacturing organizations, experts, and global health authorities.
  • Manage planning, preparation, and review of high-quality CMC related applications for assigned programs with minimal supervision.
  • Ensure that CMC-related applications, including INDs/CTAs and agency meeting requests are complete, well written, and meet all relevant requirements to achieve timely approval
  • Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance, and provide regulatory advice to project teams
  • Participate as needed in interactions with regulatory agencies. Represent RA CMC in Health Authority meetings and lead or support CMC preparation activities for meetings with Health Authorities on CMC-related matters.
  • Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation. Evaluate change proposals for regulatory impact and filing requirements.
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Participate in initiatives aimed at improving internal departmental standards and systems

Requirements / Qualifications:
  • Minimum of a Bachelor' s degree in relevant field of study.
  • 3-5 years of relevant biopharmaceutical industry experience and demonstrable track record of accomplishments with at least 1 year of experience in CMC-focused Regulatory Affairs preferably for biologics, and ideally with experience in BLA or MAA filings, late stage clinical development, and/or post-approval regulatory dossier life-cycle management. Experience with combination products preferred.
  • Fundamental, current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to articulate and apply these requirements to develop regulatory submissions.
  • Excellent presentation skills and ability to communicate effectively at multiple levels of the organization
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
  • Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
  • Able to understand and interpret data/information and its practical application.
  • Able to problem solve and apply skills to determine risk exposure and communicate potential issues to management

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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