Remote Position
[Remote] Regulatory Affairs Consultant - CMC US/EU - Mature Biological products
🌍 Remote · United States
💼 Full-time
Note: The job is a remote job and is open to candidates in USA. Parexel is hiring a CMC Regulatory Affairs Senior Associate / Consultant to lead and contribute to regulatory strategy for biologics and vaccines. The role supports global submissions, product lifecycle management, CMC documentation, and dossier gap analyses within a dedicated client program.
Responsibilities
- Lead and contribute to CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes
- Author and review high-quality CMC documentation (Modules 1-3) for global submissions
- Support and lead global submissions (US, EU, and beyond) from planning through execution
- Perform CMC dossier gap analyses and provide clear, strategic recommendations
- Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders
- Act as a key contributor within a dedicated client team, building strong, trusted relationships
- Ensure submissions meet global regulatory expectations with precision and excellence
Skills
- 3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role and 5+ years of experience for a Regulatory Affairs Consultant role
- Hands-on experience with commercial biologicals and/or vaccines
- Strong knowledge of global regulatory requirements (FDA, EMA, and international markets)
- Proven experience in global submission management
- Expertise in authoring and reviewing CMC Modules 1-3 to support variations and performing gap analyses
- A collaborative mindset with strong communication and stakeholder management skills
- Experience with Veeva Vault (RIM/eCTD systems)
- Candidates located in the eastern time zone of Canada
Benefits
- Remote work; candidates in Canadian time zones other than Eastern must be flexible to work ET hours.
- Some roles may be eligible for additional incentives, bonuses, or other compensation programs.
Company Overview
Company H1B Sponsorship