Senior CMC Regulatory Lead for Post-Approval Vaccines

Parexel; Denver (CO); Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation/Time Off

Flexible Spending / Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking an experienced Senior Regulatory Affairs Consultant (CMC) to lead strategic CMC activities for late-stage and marketed vaccines. This remote-capable role involves interaction with health authorities, cross-functional collaboration, and shaping regulatory strategy from development through lifecycle management.

You will mentor teams, oversee submissions, and stay ahead of evolving CMC regulations, with opportunities to influence programs and outcomes across R&D, Manufacturing,

Qualifications

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
• Minimum of 10 years of experience in Regulatory Affairs with a strong focus on CMC for late-stage and marketed products.
• Extensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations.
• Proven track record of successful regulatory submissions and positive health authority interactions.
• Strong analytical, communication, organization, and problem-solving skills with the ability to influence and lead at senior levels.

Responsibilities

• Provide strategic direction and oversight for CMC aspects of late-stage and marketed products, and develop comprehensive CMC strategies to support product development, registration, and lifecycle management.
• Develop and oversee CMC strategies for complex regulatory submissions, including INDs, IMPDs, BLAs, MAAs, post-approval variations and responses to health authorities.
• Author and review high-level regulatory submissions and lead cross-functional submission preparation meetings.
• Lead regulatory CMC discussions and interactions with Health Authorities and build relationships with regulatory stakeholders.
• Mentor and develop team members in Regulatory CMC practices and strategic thinking.

Skills

CMC regulatory strategy

Regulatory submissions

Health authority interactions

Cross-functional collaboration

Leadership

Education

Advanced degree in Pharmaceutical Sciences / Chemistry / Chemical Engineering

PhD (preferred) in Pharmaceutical Sciences or related field

Job description

Parexel is seeking an experienced Senior Regulatory Affairs Consultant (CMC) to lead strategic CMC activities for late-stage and marketed vaccines. This remote-capable role involves interaction with health authorities, cross-functional collaboration, and shaping regulatory strategy from development through lifecycle management.

You will mentor teams, oversee submissions, and stay ahead of evolving CMC regulations, with opportunities to influence programs and outcomes across R&D, Manufacturing,