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Manager of Investigational New Drug (IND), Regulatory Affairs

Buffalo, NY

Posted: 07/24/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2406

Our Client is looking to add a Manager of IND to their Regulatory Affairs team on a permanent basis. The person in this role will serve as Investigational New Drug (IND) regulatory affairs lead for global programs, and manage the day-to-day regulatory affairs activities for specific domestic and international investigational applications (INDs, CTAs, annual/periodic reports, etc.) for all disciplines. S/he will also coordinate multiple submissions and projects effectively. 

Essential Job Functions/Responsibilities:
  • Serve as Investigational New Drug (IND) regulatory affairs lead for global programs, manage the day-to-day regulatory affairs activities for specific domestic and international investigational applications (INDs, CTAs, annual/periodic reports, etc.) for all disciplines. Coordinate multiple submissions and projects effectively.
  • Exercise good judgment in interpretation and implementation of governmental regulations and guidances. Including developing and authoring internal procedures and company SOPs.
  • Direct interaction with regulatory agencies on defined matters. Build and maintain excellent relationships with regulatory agency personnel and representatives from partner companies.
  • Manage preparation and submission for all initial INDs/CTAs globally (scientific lead when applicable or manage science lead in this process)
  • Maintain all ongoing IND activities, e.g. annual reporting, safety reporting, amendments
  • Oversee regulatory operations for all INDs/CTAs e.g. publishing, xml building, electronic submission
  • Prepare supporting applications globally e.g. orphan drug designations, pediatric study plans
  • Manage interdepartmental regulatory matters and provide regulatory guidance to internal personnel (e.g., project teams; clinical, preclinical, and manufacturing departments, etc.)

Requirements / Qualifications:
  • Bachelor of Science degree or higher, preferably in sciences
  • Five years pharmaceutical/biotechnology industry experience, with at least three years relevant U.S. regulatory experience
  • Thorough working knowledge and understanding (application of knowledge/experience) of FDA regulations and ICH guidelines
  • Able to prioritize work and to complete assignments with minimal guidance
  • Ability to complete activities within established timelines
  • Ability to learn and assimilate scientific information
  • Experience and knowledge in the preparation of IND/CTAs and all supportive amendments or supplements; eCTD format preferred
  • Previous experience in interpretation of FDA guidances, policy statements, etc.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
  • Previous experience in managing interactions with FDA and other regulatory authorities
  • Knowledge of GMPs, GLPs, and GCPs
  • Excellent written and oral communication skills
  • Very strong computer literacy
  • RAC certification preferred

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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