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Regulatory Affairs Consultant

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Parexel

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Location:
United States , Remote

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Job Responsibility:

  • Provide regulatory strategy input for small molecule and biologic products
  • Support regulatory leads in developing contingency plans for CMC-related scenarios
  • Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
  • Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
  • Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
  • Partner with manufacturing, quality, and external organizations to address CMC-related issues
  • Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
  • Support planning and execution of Health Authority meetings, including mock sessions
  • Identify and implement process improvements to enhance regulatory efficiency and readiness
  • Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions
  • Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer
  • Ensure audit readiness and version control through meticulous documentation and system management

Requirements:

  • 4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
  • Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
  • In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics
  • Strategic and proactive mindset with strong operational execution
  • Excellent analytical, problem-solving, and negotiation skills
  • Effective communicator with strong interpersonal, presentation, and leadership abilities
  • Ability to manage multiple projects independently in a matrixed, multicultural environment
  • Proficiency in Microsoft Office Suite and regulatory systems
  • Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
  • Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred
  • RAC certification is a plus
  • Given the client's location, preference will be given to candidates residing in the Eastern Time Zone

Nice to have:

  • Previous experience with combination device products is a plus
  • RAC certification is a plus
  • Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus
What we offer:
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts

Additional Information:

Job Posted:
February 14, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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