Remote CMC Regulatory Affairs Consultant – Biologics

Parexel; Denver (CO); Remote; USD 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401(k) with Company match

Tuition Reimbursement

Vacation/Holiday/Sick Time

Zusammenfassung

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to provide regulatory strategy for biologics and small molecules, focusing on US, EU, and Canada regulatory needs. This remote role collaborates with manufacturing, quality, and global teams to prepare GMP/CMC submissions and support health authority meetings.

You will contribute to early development through post-approval changes, ensuring compliant, timely approvals and continuous improvement of processes in a fast-paced,

Qualifikationen

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or Pharm.D.
• 4–6 years CMC experience with regulatory filing
• Knowledge of GMP, drug development, and global regulations
• CM C regulatory requirements for biologics and small molecules
• Experience preparing CMC (Quality) sections for IND/NDA/DMF (FDA and Europe/Canada)
• Global regulatory environment awareness
• Proficient with Microsoft Word, Excel, PowerPoint
• Strong analytical, problem-solving and negotiation skills

Aufgaben

• Develop and implement CMC regulatory strategies for biologic and small molecule products.
• Coordinate CMC submissions for regulatory authorities.
• Prepare and review CMC and GMP documents for submissions.
• Represent CMC Regulatory Affairs in project teams.
• Support health authority meetings and CMC GRT meetings.
• Collaborate with manufacturing, quality, and cross-functional teams.
• Build relationships with internal and external stakeholders.

Kenntnisse

Regulatory strategy

Analytical problem solving

Negotiation

Cross-functional collaboration

Regulatory submissions

Ausbildung

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.

Master's or Ph.D. preferred

Tools

Trackwise Digital

TRS Viewer

Jobbeschreibung

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to provide regulatory strategy for biologics and small molecules, focusing on US, EU, and Canada regulatory needs. This remote role collaborates with manufacturing, quality, and global teams to prepare GMP/CMC submissions and support health authority meetings.

You will contribute to early development through post-approval changes, ensuring compliant, timely approvals and continuous improvement of processes in a fast-paced,