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Sr. Director, CMC Regulatory Affairs

Cambridge, MA

Posted: 08/12/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2416

Reporting to the VP/Head of Regulatory CMC, this position will lead the projects and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and marketed products that are based on RNA oligonucleotide therapeutics and/or gene therapy core platforms. The incumbent will work closely with subject matter experts and be responsible for assuring the regulatory CMC strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and in high quality. This position will provide product strategy and direction to Tech Ops, Quality, commercial and clinical teams internally, and agency engagement and alliance partner interactions externally. It requires strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions. Experience working in a matrix environment and excellent people skills are required.

Primary Roles and Responsibilities Include:
  • Lead a product platform team with responsibility to deliver all the regulatory CMC objectives
  • Lead and manage a team of FTEs, contract staff and vendors to execute the regulatory activities
  • Represent Regulatory CMC on platform/project discussions at internal meetings as well as at meetings with regulatory agencies for all CMC related issues.
  • Supervise the team to provide CMC regulatory guidance for global development and registration programs
  • Manage the dossier development process for CMC modules for IND/IMPD/CTA and BLA/NDA/MAA submissions and prepare and review submission-ready CMC and marketing registration applications, supplements, amendments and variations.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.

Education, Knowledge and Skills:
  • Ph.D. degree in a biomedical discipline with 5+ years regulatory experience or M.S. with 8+ years regulatory experience, or B.S. with 10 years regulatory experience;
  • Experience with preparing INDs, IMPDs, NDA and/or MAA submission(s) is essential.
  • Strong knowledge and experience in CMC product development
  • Established knowledge of regulatory CMC guidelines and regulations (US and international).
  • Prior experience in agency engagement and interactions.
  • Regulatory experience supporting both development projects and marketed products.
  • Prior hands on experience of FDA CMC regulatory submissions is essential.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Experience with people management is required.
  • Possesses strong written and verbal communication and presentation skills.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong team player that has a customer service approach and is solution oriented.
  • Must thrive working in a fast-paced, innovative environment demonstrating flexibility and a proactive approach.
  • Excellent interpersonal and negotiation skills with the ability to develop important relationships with key stakeholders.
  • Ability to manage conflict and analyze complex issues to develop relevant and pragmatic plans, programs and recommendations.
  • Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues to a broad audience.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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