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Senior Manager, Regulatory Affairs

New York, NY

Posted: 09/24/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2613

Job Description

Our client is seeking a Senior Manager of Regulatory Affairs to be based in its New York City headquarters (remote to start, thereafter partially remote). The incumbent will primarily serve as a regulatory representative, initially working with senior regulatory team members, on one or more clinical phase programs in collaboration with the greater regulatory team. The role is intended for a proactive and flexible regulatory professional with the ability to support activities required to progress our novel therapeutic program(s) to registration. The Senior Manager will report directly to the Director of Regulatory Affairs and support the Regulatory Affairs team in various capacities. He/she will be responsible for co-developing and executing regulatory plans for assigned programs together with the greater regulatory team, and as a subject matter expert, will be relied upon to articulate clear and compelling regulatory strategy, highlighting risks and opportunities, when appropriate.

Key Responsibilities:
  • Co-develops and implements innovative global regulatory strategies together with the greater regulatory team for assigned programs through collaboration with a cross functional project team and consensus-building with internal and external stakeholders.
  • Leads team in the development and execution of key deliverables to support regulatory submission strategies and planning, coordination, and preparation for successful interactions with regulatory authorities, together with the greater regulatory team.
  • Effectively communicates the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs management as needed
  • Maintains awareness of the evolving regulatory landscape and advises team and management of changes with potential strategic impact to future development. Interprets regulations, guidelines, and policy statements on a global level
  • Coordinates timely submissions to health authorities and monitors reporting requirements to maintain compliance with applicable regulations where needed
  • Interact with company partners and consultants for various regulatory matters, as needed

  • Bachelor’ s or Master’ s degree in life sciences with ~3– 5 years of pharmaceutical/biotechnology industry experience in Regulatory Affairs; Advanced degree (PhD, PharmD) preferred
  • Experience in the preparation and successful submissions of regulatory submissions in key ICH regions (e.g. US INDs, Canadian and EU CTAs, etc.)
  • Experience interfacing with FDA and/or other global Health Authorities
  • Strong leadership and project management skills, including demonstrated cross-functional communication, negotiation and conflict management skills
  • Ability to represent regulatory affairs group in project teams, committees, and external meetings, as well as with partners and collaborators
  • Comprehensive working knowledge of applicable regulations in ICH regions and solid knowledge of GCPs and GLPs
  • Travel: minimal travel may be expected

Meet Your Recruiter

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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