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Remote: Associate Director Regulatory Affairs

Company: Shepherd Regulatory Search
Location: Kansas City
Posted on: June 24, 2022

Job Description:

Remote Position
Organization: My client is a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated therapeutics to treat autoimmune, inflammatory, and other debilitating diseases.
Role: Reporting to the Vice President of Regulatory Affairs, the Associate Director Regulatory Affairs will assist with and manage regulatory submissions and lead the development of strategies in accordance with therapeutic area direction.

  • Participate in cross-functional project teams to deliver successful submissions/filings and outcomes with Health Authorities (HA) for therapeutic programs
  • Serve as a regulatory contact for designated trials: assist with developing timelines, preparing and maintaining clinical trial applications, track status of submissions, and Health Authority commitments. Coordinate with CROs or vendors on clinical trial activities in support of regulatory goals
  • Collaborate with team members to draft responses to health authority requests
  • Ensure consistency, completeness, accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
  • Contribute to the regulatory strategy, including identifying and communicating potential risks and mitigation plans associated with regulatory strategies
  • Contribute to interactions with Health Authorities, including assisting in developing briefing packages and prep meetings
  • Prepare regulatory operations Standard Operating Procedures (SOPs); provide regulatory review of SOPs from other departments as necessary
  • This position is eligible to work from home, with occasional travel to the office required, work from the office, or a combination of working from home and the office.
    • BA/BS degree, preferably in the life sciences, Advanced Degree preferred.
    • Minimum 8 years of Regulatory Affairs experience is required.
    • Direct experience in preparing registration (IND, NDA, CTA, and/or NDS) submissions required.
    • Track record of leading regulatory activities for development program(s).
    • Strong knowledge of FDA guidelines for the development of small molecule products is preferred.
    • Experience working with Health Canada and filing CTA and NDS submissions is preferred.
    • Strong project management and organizational skills with emphasis on attention to detail.
    • Excellent interpersonal and verbal/written communication skills with the ability to build relationships at all levels of the organization.
    • Ability to work independently on multiple projects with tight timelines and minimal supervision.
    • Experience working with CROs on regulatory submissions in support of clinical trials.
    • Proficient at using MS Office products.
    • Experience with cloud-based document management programs and/or document management systems and co-authoring tools is preferred.
    • Ability to travel domestically and internationally as needed

Keywords: Shepherd Regulatory Search, Kansas City , Remote: Associate Director Regulatory Affairs, Executive , Kansas City, Kansas

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