Regulatory Affairs Consultant

This growing biopharmaceutical company is developing medicines for patients who suffer from serious genetic diseases and cancers.  They have one approved product and another program currently in Phase 2 trials.  They are seeking a Regulatory Affairs Consultant who can help to develop and execute global regulatory strategies for the company’s rare disease and oncology programs.   This engagement will be approximately 20-30 hours a week for about 3-6 months.  This is a remote role.


  • Develop regulatory strategies for rare disease and oncology programs in development
  • Provide guidance and support to cross-functional teams, and execute defined regulatory activities.
  • Maintain regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission deliverables.
  • Serve as regulatory lead or co-lead on assigned drug project teams, providing regulatory guidance and recommendations that are in line with the company goals, international laws, and regulations, including but not limited to:
    • Phase 2 – 3 development activities
    • Health authority meetings related to drug development and marketing applications
  • Lead and/or support strategy and execution of amendments/supplements and other policies and procedures as assigned
  • Conduct Regulatory Intelligence related to the assigned programs and disseminate relevant information to Sr. Management and cross-functional teams.
  • Assist with all regulatory business development efforts as needed
  • Manage other regulatory activities as assigned, which may involve nonclinical studies and strategies, and commercial activities


  • Bachelor’s degree in a scientific field is required. Advanced degree such as PharmD, MD, or PhD preferred
  • A minimum of 10 years of Regulatory Affairs experience with pharmaceutical drugs and/or biologics.
  • Regulatory experience with rare disease programs and/or oncology experience highly desired.
  • Must have track record of filing successful INDs, CTAs, NDAs or BLAs.
  • Must have strong experience working directly with FDA and other health authorities.
  • Be well-versed in the drug development process and regulatory requirements, and have a good understanding of the underlying science.
  • Global/Ex-US Regulatory filing experience (EMA, Asia Pacific, etc) required.
  • Excellent written and verbal communication 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; management also of non-regulatory functional activities is preferred
  • Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledge of global operational regulations and guidelines
  • Excellent written and oral communication skills
  • Demonstrated influencing and leadership skills
  • Fluent with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat PDF rendering software


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

Apply for this Position

Your Name*

Your Email*


Your Message

This entry was posted in . Bookmark the permalink.