Remote CMC Regulatory Strategist (Post-Approval)

Parexel; Juneau (AK); Remote; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Tuition Reimbursement

401(k) with Company match

Work/Life Balance

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant in a remote role to support post-approval regulatory activities. You will be critical in developing submission strategies and ensuring compliance with CMC regulations.

Collaboration with cross-functional teams is essential. This position requires a Bachelor's degree in Chemistry or a related field, with 5+ years of experience in regulatory affairs, particularly in the pharmaceutical sector.

Qualifications

• 5+ years of experience in regulatory affairs, especially in technical/CMC roles.
• Strong understanding of CMC and post-approval regulatory requirements.
• Ability to collaborate and communicate with stakeholders.

Responsibilities

• Develop CMC submission strategies for post-approval activities.
• Assess change controls and provide regulatory assessments.
• Coordinate submission preparation with cross-functional teams.

Skills

CMC regulatory strategy

Regulatory affairs experience

Quality documentation

Collaboration and communication

Regulatory information management

Attention to detail

Problem-solving skills

Education

Bachelor’s in Chemistry or Life Sciences

Tools

Word

PowerPoint

Excel

Veeva Vault

Job description

Parexel is seeking a Regulatory Affairs Consultant in a remote role to support post-approval regulatory activities. You will be critical in developing submission strategies and ensuring compliance with CMC regulations.

Collaboration with cross-functional teams is essential. This position requires a Bachelor's degree in Chemistry or a related field, with 5+ years of experience in regulatory affairs, particularly in the pharmaceutical sector.