VP Regulatory Affairs

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Job Description

Position Summary:

 

VP Regulatory Affairs will be responsible for developing a regulatory organization that provides strategic leadership and operational excellence in cross-functional teams to assure the highest standards of Regulatory Affairs, GCP and GMP across all development and commercial programs.                        

 

Key Activities:

 

  • Regulatory strategy and intelligence.
  • Regulatory operations, agency interactions, and submissions, both domestically and globally, from IND to marketing applications.
  • Presentations to regulatory scientific advisory committees.
  • Labeling strategy and execution.
  • Regulatory strategy and compliance related to CMC activities.
  • Regulatory audits by competent authorities.
  • Engagement and management of external regulatory CROs to supplement internal expertise and resources.
  • Pharmacovigilance-related communication with health authorities.
  • In alignment with company goals, develop and lead the implementation of regulatory strategies throughout all stages of clinical and commercial development including regulatory chemistry, manufacturing and controls (CMC) activities.
  • Design regulatory strategies and build a stage-appropriate team(s) to support business decisions, product applications and claims, from development through product lifecycle management.
  • Oversee all required regulatory submissions.
  • Be the primary point of contact (or delegate) for all regulatory correspondence and identification of appropriate technical experts
  • Keep company leadership apprised of changes to the regulatory landscape affecting existing and future Company products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
  • Develop and design effective regulatory structures, processes and procedures and budget forecasting
  • Provide guidance to business development regarding critical evaluation of potential product opportunities.
  • Provide regulatory review and approval of external communications related to clinical trials and marketing of approved products.
  • Build and manage a Medical Writing team to support ongoing clinical development activities.
  • Ensure that these functions evolve to meet the needs of a maturing pharmaceutical company and ensure compliance with regulations.
  • Ensure adequacy of recording, summarizing, and handling of adverse events for investigational products including decisions on seriousness, expectedness, and causality for regulatory audiences.
  • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.

 

Required Qualification:

 

  • Bachelor’s degree in life sciences with at least 10 years regulatory experience in a major pharmaceutical and/or biotech company or regulatory agencies.
  • Experience in regulatory strategy for small molecule disease products.
  • Experience in leading regulatory teams and a track record of successful submissions and approvals.
  • Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP guidelines.
  • Possess strong interpersonal, organization, planning, management, and communication (oral and written) skills.
  • Have an entrepreneurial and highly self-motivated character capable of proposing innovative solutions to regulatory problems.

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Details

Posted: Sep 24, 2020

Type: Full Time

Category: Regulatory Affairs