Remote Senior CMC Regulatory Affairs Consultant – Vaccines

Parexel; United States; Remote; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking an experienced Senior Regulatory Affairs Consultant to lead CMC regulatory activities for late-stage and marketed vaccine products in a remote capacity in the United States.

You will collaborate with R&D, Manufacturing, Quality Assurance, and Clinical Development to shape CMC strategy, manage health authority interactions, and ensure timely, high-quality submissions. This role offers strategic leadership, ongoing professional growth, and a global scope.

Qualifications

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field.
• Minimum 10+ years of Regulatory Affairs experience with 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 project management and leadership ability.

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 supplements, and responses to health authority questions.
• Author and review high-level regulatory submissions, ensure submissions conform to health authority guidelines, and lead submission prep meetings with cross-functional input.
• Lead regulatory CMC discussions and interactions with Health Authorities, represent the company in high-level meetings with regulators, and build relationships with stakeholders.
• Develop strategies for addressing complex regulatory questions and issues, and address reviewer comments and regulatory correspondence.
• Oversee regulatory assessments of manufacturing changes and provide expert guidance on CMC implications of proposed changes.
• Represent Regulatory CMC at high-level project team meetings and lead submission prep meetings and strategy discussions.
• Work with senior leaders across R&D, Manufacturing, QA, and Clinical Development to facilitate communication between teams and regulators.
• Provide updates to senior management on status, risks, and milestones; provide expert CMC guidance for decisions and lifecycle management.
• Mentor and develop team members in Regulatory CMC practices and strategic thinking.
• Stay at the forefront of evolving CMC regulations and participate in industry groups and regulatory initiatives.

Skills

CMC regulatory strategy

Regulatory submissions

Health authority engagement

Regulatory strategy leadership

Cross-functional collaboration

Education

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field

PhD in Pharmaceutical Sciences / related field

Job description

Parexel is seeking an experienced Senior Regulatory Affairs Consultant to lead CMC regulatory activities for late-stage and marketed vaccine products in a remote capacity in the United States.

You will collaborate with R&D, Manufacturing, Quality Assurance, and Clinical Development to shape CMC strategy, manage health authority interactions, and ensure timely, high-quality submissions. This role offers strategic leadership, ongoing professional growth, and a global scope.