Senior Regulatory Affairs Consultant, CMC Biologics Remote

Parexel; Denver (CO); Remote; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will support regulatory strategy and compliance across development to marketed products for large biopharmaceutical partnerships.

The role involves preparing regulatory submissions, ensuring GMP compliance, and collaborating with manufacturing, quality, and project management teams to drive global market access. A strong CMC background is essential.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)
• 7+ years of CMC experience in the pharmaceutical industry with a demonstrated history of successful regulatory filing documentation
• Comprehensive knowledge of drug development processes, pharmaceutical technology, drug manufacturing processes, and GMP requirements
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products
• Comprehensive experience preparing CMC (Quality) sections for IND, NDA, DMF for FDA and Europe/Canada submissions
• Global regulatory environment understanding
• Strong analytical, problem-solving, organizational, and negotiation skills
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
• MS Office proficiency in regulatory docs and submissions

Responsibilities

• Develop CMC regulatory strategies and contingency plans for biologics and small molecules.
• Determine regulatory and technical requirements for CMC and GMP submissions.
• Represent CMC regulatory affairs in cross-functional project team meetings and provide regulatory guidance.
• Prepare and review all CMC and GMP-related submission documents.
• Develop CMC regulatory strategies for development through marketing applications; support post-approval changes.
• Coordinate with manufacturing, quality and partners on CMC issues.
• Build relationships with global units, contract manufacturers and external partners.
• Prepare for health authority CMC meetings and mock meetings.
• Suggest improvements to CMC regulatory processes and increase efficiency.
• Proficiency with CREDO, ORIOM, Trackwise Digital, and TRS Viewer

Skills

CMC experience

Regulatory analysis

Regulatory strategy

CMC documentation

Global regulatory knowledge

Analytical skills

Negotiation skills

MS Office

Education

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

Master's degree or Ph.D. in related field

Tools

CREDO

ORIOM

Trackwise Digital

TRS Viewer

Job description

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will support regulatory strategy and compliance across development to marketed products for large biopharmaceutical partnerships.

The role involves preparing regulatory submissions, ensuring GMP compliance, and collaborating with manufacturing, quality, and project management teams to drive global market access. A strong CMC background is essential.