Regulatory Affairs Consultant

Job Title: Regulatory Affairs CMC Consultant - Vaccines

Location: Global / Remote

Contract Duration: 3-9 months

Hours: Up to 140 hours/month

Sector: Vaccines / Biologics

Start: ASAP

Company Overview:

Apsida Life Science is partnering with a leading global biopharmaceutical services and contract research organisation (CRO), supporting pharmaceutical and biotechnology companies across clinical development, regulatory affairs, market access, and related life-science services. The organisation operates internationally and works with clients across a broad range of therapeutic areas and global markets.

Key Responsibilities:

• Perform global regulatory assessments of CMC Change Control Requests (CCRs), including assessment of registered information, regulatory commitments, applicable regulations and market requirements.
• Conduct regulatory assessments using STARR, Veeva Vault, RSID and relevant regulatory databases.
• Lead submission planning, including determination of regulatory strategy, content, timelines and market sequencing.
• Coordinate with affiliates, RSOs, SMEs, PFPs and other stakeholders to ensure submissions are appropriately planned and executed.
• Coordinate preparation, writing, review and approval of CMC variation packages.
• Coordinate cross-site submission activities and dispatch of CMC dossiers to affiliates.
• Support responses to Health Authority questions, including coordination with affiliates, RSOs and impacted SMEs.
• Provide technical CMC input into responses where required.
• Maintain and update regulatory records and Health Authority question tracking in Veeva Vault.
• Support regulatory assessments for new markets and market extensions, including review of open change controls and assessment of their impact on new registrations.
• Analyse change control information, STARR data, local regulations, guidance and existing CTD dossier content to determine appropriate regulatory strategies.
• Support Veeva regulatory data remediation and ensure regulatory statuses are updated accurately and on time.
• Provide ad hoc CMC regulatory support and participate in relevant stakeholder meetings.

Requirements:

• Regulatory Affairs experience within CMC, ideally within vaccines or biologics.
• Strong experience in CMC change control assessments and regulatory variations.
• Experience supporting Health Authority questions and responses.
• Strong understanding of CTD Modules 1, 2.3 and 3.
• Experience with regulatory requirements across EU, US and other major global markets.
• Good understanding of EU and US regulatory guidelines.
• Experience working with Veeva Vault and regulatory tracking systems.
• Experience with Veeva regulatory data remediation.
• Experience coordinating regulatory projects across multiple stakeholders and markets.
• Strong project and meeting management skills.
• Highly organised, proactive and able to work independently.

If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:

[Confidential Information]

+44 744 134 1041

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.