CMC Regulatory Affairs Associate, M3 Authoring Experience for Biological Products

• Conduct and deliver high-quality, on-time CMC regulatory activities, including compliant management of internal tools and client systems
• Author administrative and CMC regulatory documents and deliverables
• Collaborate with project SMEs and client stakeholders to prepare submission packages
• Manage CMC submissions, including planning, submission package compilation, RtQ preparation, and responses to spontaneous Health Authority queries
• Coordinate submissions by updating trackers, agreeing timelines with LRAs and GRA-CMC, and attending recurring meetings with LRAs
• Create submission binders and Global Content Lists/Submission Content Plans
• Coordinate publishing activities and review eCTD sequences
• Act as the main GRA point of contact for LRAs and other stakeholders
• Coordinate all assigned activities
• Ensure compliance with client SOPs and training sessions
• Support regulatory strategies and successful submissions contributing to medical advancements

• University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD)
• Degree in Regulatory Affairs is advantageous
• Minimum of 5 years’ experience in the biotech or pharmaceutical industry
• At least 5 years in Regulatory Affairs CMC for Senior level and 2 years for Associate level
• Experience with biological products (mandatory)
• Experience with vaccines (preferable)
• M3 authoring experience (mandatory)
• Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia)
• Regulatory CMC writing skills and ability to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements
• Knowledge of Good Manufacturing Practice or related areas highly regarded
• Experience using Veeva
• Excellent communication and stakeholder management skills
• Strong organizational and time management skills
• Strong problem-solving skills
• Strong oral and interpersonal skills
• Proven ability to work efficiently as part of a team
• Ability to comply with client SOPs and training requirements

• Opportunities for growth and impact within a collaborative and forward-thinking team environment