Senior/Principal Regulatory Affairs Specialist, CMC

Role Overview

• Provide high quality client support and interface in terms of the provision of strategic regulatory CMC intelligence, guidance and regulatory expertise for product development from preclinical through registration and product lifecycle management
• Author CMC documentation to support regulatory filings e.g. EU IMPDs, simplified IMPDs, US IND Module 3 and Canadian QOS
• Apply in-depth understanding of regulatory guidance and regulations to the preparation of CMC documents and sections for a variety of submissions or other documents, as required
• Review CMC documents and ancillary documents and reports for completeness and accuracy and for compliance with regulations
• Interface with other regulatory departments within PPD Regulatory Affairs and represent the CMC function on multidisciplinary project teams
• Prepare CMC sections of Regulatory Authority scientific advice briefing books e.g. EMA, UK MHRA and US FDA
• Collaborate with project team stakeholders to manage and coordinate the authoring, review, and finalization of CMC documents in accordance with submission timelines, keeping all stakeholders, including clients, informed of progress
• Research and utilizes information to ensure high quality and regulatory compliant strategies and submissions
• Coordinate the timely and accurate assembly of responses to inquiries from Regulatory Authorities on CMC content of regulatory submissions
• Identify project issues and contributes to development of alternate strategies as required

Requirements

• Ideally candidates will have a degree (or equivalent) and higher degree e.g. Chemistry, Biochemistry/Molecular Biology and Pharmaceutical Sciences
• Ideally, some prior regulatory affairs experience with a CMC background
• Some knowledge of ICH and other global regulatory guidelines
• Some knowledge of CMC Regulatory requirements, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products
• Awareness of the contents of clinical trial applications and marketing authorisation applications, preferred
• Ideally some prior experience authoring CMC documents to support filings of CTAs and MAAs for NCEs, biopharmaceuticals and Advanced Therapy Medicinal Products
• Knowledge of biopharmaceutical and or pharmaceutical; development, testing or manufacturing preferred
• English language (written and spoken) as well as local language where applicable
• Experienced with Microsoft Office applications, e.g. Word, Excel, Visio, PowerPoint
• Microsoft Word authoring and formatting skills are essential for this role
• Effective oral and written communication skills
• Good organizational and planning skills
• Effective negotiation skills
• Ability to work on own initiative and plan and prioritize work load to meet client deadlines
• Proven ability to work effectively in a team environment
• Some knowledge of global / regional / national country CMC requirements / Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management
• Good judgement and decision-making skills
• Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management and other Thermo Fisher Business Groups)
• Some knowledge of budgeting, forecasting and the CRO business model preferred.

Tech Stack

• Assembly

Benefits

• Health insurance
• Professional development opportunities