Senior Regulatory Affairs Consultant

Our client is one of the largest providers of reproductive healthcare drugs.  They have one approved product and a robust pipeline of women’s health programs in development.  They are seeking a Senior Regulatory Affairs Consultant who can provide strategic regulatory expertise and leadership for the company until a new Head of Regulatory & Quality can be hired.   Reporting into the CEO, this engagement will be approximately 40 hours a week for about 3-6 months.  This is a remote role.


  • Lead regulatory affairs and for approved and pipeline products (including business development assessments).
  • Develop and execute regulatory strategies and provide regulatory support for all operational, manufacturing, clinical and nonclinical activities.
  • Lead interface with the FDA and other regulatory agencies as needed.
  • Lead, manage and prepare regulatory submissions for on-market and development programs (i.e., ANDA/NDA, Pre-IND/IND, REMS) including supplements, annual reports, IND safety reports, study protocols and study reports) to ensure compliance with FDA and other requirements.
  • Provide regulatory advice for all development activities, including review or authoring of essential regulatory documents.
  • Provide oversight of quality assurance.
  • Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
  • Provide regulatory support for CMC, REMS and other activities including regulatory manufacturing submission documents, quality and safety oversight.
  • Develop, implement and maintain regulatory process, procedures and compliance operations.
  • Keep senior management informed and advised of all key regulatory and quality assurance issues.


  • Bachelor’s degree in a scientific field is required. Advanced degree such as PharmD, MD, or PhD preferred
  • A minimum of 15 years of Regulatory Affairs experience with pharmaceutical drugs and/or biologics.
  • Regulatory experience with Women’s Health programs desired, but not required.
  • Demonstrated track record of expertise and hands-on execution of regulatory affairs in small-medium pharmaceutical company.
  • Broad experience across NDA, ANDA, 505b2, IND, CMC, clinical, REMS, and other domains, and ability to effectively anticipate, prevent and solve challenges.
  • Excellent written and verbal communication skills.
  • Demonstrated influencing and leadership skills.
  • Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately.
  • Ability to prioritize multiple urgent priorities and experience with wearing multiple hats.
  • Strong interpersonal and agency management skills.


Note: All contractors must be authorized to work in the United States.  H1B sponsorship is not available.

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