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Senior Regulatory Associate

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Parexel

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Research and Development

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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:

  • Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests
  • Prepare and review CMC packages
  • Support GMP submissions
  • Manage change control assessments
  • Ensure compliance with regulatory requirements across multiple regions
  • Conduct and deliver high quality, on time CMC regulatory activities, including compliant management of all internal tools and client systems
  • Author Administrative and CMC regulatory documents/deliverables and collaborate with project SMEs and client stakeholders to prepare submission packages
  • Full management of CMC submissions (i.e. planning, submission package compilation, RtQ preparation, Spontaneous HA queries, etc.)
  • General submission coordination: Submissions planning (tracker update, timelines agreement with LRA and GRA-CMC, recurrent meetings with LRAs), create submission binders and Global Content List/Submission Content Plans, coordinate the publishing aspect, review of eCTD sequences
  • Act as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)
  • Coordinate all assigned activities
  • Ensure compliance to all client SOPs/training sessions

Requirements:

  • University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD)
  • Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC
  • Sound knowledge in natural sciences with a focus on biological/vaccines/small molecule medicinal products
  • Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia)
  • Strong regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements
  • Knowledge in Good Manufacturing Practice or related areas would be highly regarded
  • A degree in Regulatory Affairs is advantageous

Nice to have:

  • Communicator
  • Detail-oriented
  • Problem-solver
  • Relationship-builder
  • Results-driven
  • Strategic
What we offer:
  • Flexible work arrangements
  • Opportunities for career growth
  • Diverse and global client exposure
  • Learn from experts
  • Supportive and inclusive environment

Additional Information:

Job Posted:
January 04, 2026

Work Type:
Remote work
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