Senior CMC Regulatory Lead — Vaccines (Remote)

Parexel; Oregon; Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

401(k) with Company match

Work/Life Balance

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant (remote) to lead CMC strategies for late‑stage and marketed vaccines and therapeutics. You will drive regulatory submissions, coordinate with health authorities, and shape lifecycle management with senior leadership across R&D, Manufacturing, Quality Assurance, and Clinical Development.

Ideal candidates bring a strong track record in global CMC regulatory requirements and a patient‑focused, detail‑oriented mindset.

Qualifications

• Experience in regulatory affairs with emphasis on CMC for late‑stage and marketed products.
• Strong analytical, communication, organization, and problem‑solving skills.
• Proven track record of successful regulatory submissions and health authority interactions.

Responsibilities

• Provide strategic direction for CMC aspects of late‑stage and marketed products and develop comprehensive CMC strategies.
• Lead regulatory CMC discussions and interactions with Health Authorities and build relationships with regulatory stakeholders.
• Author and review high‑level regulatory submissions and coordinate cross‑functional input.”
• Mentor and develop team members in Regulatory CMC practices and strategic thinking.
• Stay current on evolving CMC regulations and participate in industry groups.

Skills

CMC strategy

Regulatory submissions

Health authority engagement

Cross-functional collaboration

Regulatory leadership

Education

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering

Job description

Parexel is seeking a Senior Regulatory Affairs Consultant (remote) to lead CMC strategies for late‑stage and marketed vaccines and therapeutics. You will drive regulatory submissions, coordinate with health authorities, and shape lifecycle management with senior leadership across R&D, Manufacturing, Quality Assurance, and Clinical Development.

Ideal candidates bring a strong track record in global CMC regulatory requirements and a patient‑focused, detail‑oriented mindset.