Remote Senior Regulatory Affairs Consultant CMC Biologics

Parexel; Jackson (MS); Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Health insurance

Vision & dental insurance

Tuition reimbursement

Paid time off

401(k) match

Pet insurance

Job summary

Parexel, a global clinical development partner, seeks a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will shape regulatory strategy for biologics and small molecules, prepare submissions, and ensure GMP compliance across FDA/EMA/Health Canada pathways.

You will collaborate with manufacturing, quality, and project teams, support health authority meetings, and drive post-approval changes while expanding expertise in regulatory affairs and pharmaceutical development.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD).
• 7+ years of CMC experience with regulatory filing documentation.
• Comprehensive knowledge of drug development, GMP and CMC requirements.
• Experience preparing CMC sections for IND/NDA/DMF submissions (FDA/Europe/Canada).
• Strong analytical, organizational, and negotiation skills.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules.
• Prepare and review CMC and GMP submission documents for authorities.
• Collaborate with manufacturing, quality, and project teams for regulatory input.
• Support health authority meetings and post-approval changes.
• Provide regulatory guidance to cross-functional teams.
• Represent CMC regulatory affairs in project meetings.
• Assist with regulatory inquiries and ensure compliance with guidance.
• Develop processes to improve departmental efficiency.
• Maintain relationships with global sites and partners.
• Utilize tools such as TrackWise and TRS Viewer for submissions.

Skills

Strategic thinking

Regulatory analysis

Problem-solving

Collaboration

Communication

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)

Master's degree or Ph.D. in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology

Tools

Microsoft Office

Job description

Parexel, a global clinical development partner, seeks a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will shape regulatory strategy for biologics and small molecules, prepare submissions, and ensure GMP compliance across FDA/EMA/Health Canada pathways.

You will collaborate with manufacturing, quality, and project teams, support health authority meetings, and drive post-approval changes while expanding expertise in regulatory affairs and pharmaceutical development.