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Director, Regulatory Affairs

Evanston, IL

Posted: 03/03/2021 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2735

Job Description


The Director, Regulatory will direct and manage Regulatory Affairs activities for the company. Incumbent will develop and implement regulatory strategies that ensure the advancement of our Client’ s development programs. Provides guidance and counsel to senior management, R&D and clinical project teams on regulatory matters. Has responsibility for regulatory operations and ensures the timely preparation of organized and scientifically valid regulatory submissions. Confidently interacts with and represents the company to the appropriate regulatory agencies.

Essential Functions:
  • Provides technical guidance on regulatory requirements to company leadership and to project teams 
  • Anticipates regulatory obstacles and emerging issues throughout the pharmaceutical product development lifecycle and proactively develops tactics and strategy with other members of the project team
  • Leverages CNS experience to assess development programs against regulatory requirements and pathways. Develops and executes regulatory strategy for company-prioritized indications
  • Lead communicator with regulatory agencies. Acts as the principal contact with the FDA and attends all FDA conference calls and meetings. For ex-US agencies, will serve as regulatory representative
  • Acts as regulatory project manager for US and ex-US.  Provide timely and clear communications with FDA as required. Interfaces with ex-US regulatory contractors as needed for clinical-trial authorization and other health authority interactions.
  • Directs the preparation of regulatory submissions; creates submission teams, as needed, with subject matter experts (internal and external). Has direct responsibility for administrative matters and sections in regulatory submissions (e.g., cover letters, forms, SPAs, meeting requests, briefing documents, annual reports)
  • Contributes to project teams providing regulatory expertise and guidance on regulatory matters. Regulatory reviewer of clinical protocols and reports.
  • Works with BD and commercial teams to develop key messages about company technology and investigational products
  • Formulates company procedures to respond to regulatory authority queries. Develops follow-up program to address audit findings and monitors ongoing vendor/supplier compliance.
  • Ensures compliance to FDA regulations and regulations of non-US agencies that regulate drug development and approval. Identifies, assesses and incorporates best industry practices to assure regulatory compliance including preapproval compliance activities.
  • Manages and maintains appropriate policies and procedures to ensure regulatory compliance
  • Works with Quality Assurance to ensure consistent approach to compliance
  • Develops and conducts training for employees, as necessary
  • Budgetary responsibility for Regulatory Affairs. Prepares budgets and identifies appropriate external resources as needed

Requirements / Qualifications:
  • Master’ s degree required. PhD in life sciences preferred.
  • Minimum of 15 years of experience in regulatory within the biotech and/or pharmaceutical industry and at least 10 years of relevant North American and Global Regulatory experience
  • Experience in the CNS therapeutic area preferred
  • Demonstrated proficiency managing regulatory matters in a CNS portfolio
  • Experience managing a quality function (GMP, GCP, GLP)
  • Excellent knowledge of US regulatory requirements
  • Preference for experience with and knowledge of small molecule development (Phase 1 through NDA and post-approval), including CMC, nonclinical, and clinical research.
  • Track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical/biotech compounds
  • Experience in regulatory affairs outside the US, including support of Phase 2 and Phase 3 clinical development
  • Experience in a successful leadership role in developing and managing a team capable of developing and registering candidate drugs through to marketing approval
  • Acute sense of ethics and ability to work in a highly regulated environment
  • Experience in actively participating in a due diligence evaluation
  • Excellent understanding of the drug development process
  • Ability to build effective relationships with health authorities as well as with internal stakeholders and employees

Meet Your Recruiter

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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