Remote Senior CMC Regulatory Affairs Consultant (Biologics)

Parexel; Concord (NH); Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending Accounts

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join our team in a remote capacity. You will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for large biopharma partnerships, contributing to global submissions and lifecycle management.

The role requires strong CMC expertise, collaboration with manufacturing, quality, and project teams, and a track record of regulatory filings.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD) required.
• 7+ years of CMC experience with regulatory filing documentation.
• Knowledge of drug development processes and GMP requirements.
• Experience preparing CMC sections for IND/NDA/DMF submissions.
• Understanding of global regulatory environments.
• Strong analytical, problem-solving, organizational, negotiation skills.
• Excellent communication and presentation abilities.
• Ability to work independently in a matrixed setting.
• Proficiency with Microsoft Office applications.

Responsibilities

• Develop CMC regulatory strategies and contingency plans for biologics and small molecules.
• Determine regulatory requirements for CMC and GMP submissions.
• Represent CMC regulatory affairs in project meetings and provide guidance to teams.
• Prepare and review CMC and GMP documents for regulatory submissions.
• Develop strategies from development through marketing applications and post-approval changes.
• Collaborate with manufacturing, quality, and partners to address CMC issues.
• Maintain relationships with local/global units and contract manufacturers.
• Support health authority meetings and mock sessions.
• Identify opportunities to improve CMC regulatory processes.

Skills

Strategic thinking

Regulatory analysis

Problem-solving

Attention to detail

Team collaboration

Communication

Project management

Independent work

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)

Master's degree

PharmD

PhD

RAC

Tools

Microsoft Office

CPP eCATS

NextGen portals

Job description

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join our team in a remote capacity. You will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for large biopharma partnerships, contributing to global submissions and lifecycle management.

The role requires strong CMC expertise, collaboration with manufacturing, quality, and project teams, and a track record of regulatory filings.