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Sr. Manager, CMC Regulatory Affairs

Cambridge, MA 02142

Posted: 08/12/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2426

This position reports to the VP, Head of Regulatory CMC, and will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and marketed small molecule and/or gene therapy products. The incumbent will work closely with subject matter experts and be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. This is a hands on role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions. This position will provide product strategy and direction to commercial and clinical teams. Experience working in a matrix environment and excellent people skills are required.

Responsibilities include:
  • As a member of the project teams, provide CMC regulatory guidance for global development and registration programs (e.g. IND/IMPD/CTAs, NDA/BLA/MAAs). Primary regulatory representative for assigned projects at internal meetings
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
  • Prepare CMC dossiers, either with CMC functional areas or hands-on, for clinical trial and registration applications, supplements, amendments and variations.
  • Manage the review, comments resolution and approval process to ensure ready for transfer to Reg Ops for subsequent activities
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • May manage contract staff and vendors as needed to support Regulatory activities.

Requirements / Qualifications:
  • BS/MS/Ph.D. degree in a biomedical discipline with 8 + years’ related experience.
  • Experience with preparing INDs, IMPDs, NDA/BLA and/or MAA submission(s) is desired.
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • 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.
  • Regulatory experience supporting both development projects and marketed products.
  • Prior hands on experience of FDA CMC regulatory submissions is desired
  • Knowledge of eCTD elements and structure and regulatory writing skills.
  • Possesses strong written and verbal communication and presentation skills.
  • Team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Candidates must be authorized to work in the U.S.

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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