Regulatory Consultant, CMC-EU, GCC, AU

🕒 July 29

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 55%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 104 days.
• Jobs at this company usually fill in 21 days.
• Reposted once.
• No salary listed.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Conduct regulatory research and prepare gap analyses, product development plans, and regulatory submissions • Prepare or contribute to IND, pre-approval, product registration, and post-approval regulatory agency submissions • Prepare briefing packages for regulatory agency meetings and scientific advice • Support regulatory agency interactions • Manage and operationalize day-to-day regulatory activities for assigned projects • Participate as regulatory support on multidisciplinary teams throughout product lifecycles • Act as a subject matter expert and troubleshoot project-related problems • Prepare estimates for regulatory services proposals • Support client meetings, project status discussions, and business development activities • Ensure compliance with global regulatory requirements and company policies and processes • Prepare training materials and share regulatory best practices internally and externally • Support internal and external project audits • Participate in internal cross-functional initiatives • Create and maintain SOPs and process documentation • Provide oversight and guidance to team members • Maintain individual training records and complete required training

🎯 Requirements

• CMC authoring exposure • Independently authored CTD Module 3 (M3) sections • Experience with post-approval variations/supplements • Cross-functional interaction with analytical, formulation, and manufacturing teams • CMC writing and lifecycle management for small molecules • Experience across EU, USFDA, AU, GCC, and/or ROW (not all required) • Ability to own CTD sections • Ability to interpret technical data • Ability to write content from raw CMC documents • Ability to defend content in authority queries • Knowledge of section numbers and expectations • Ability to conduct research of existing product data relative to global or regional regulatory requirements • Ability to prepare or contribute to administrative and technical components of regulatory agency submissions • Ability to prepare briefing packages and support agency interactions • Ability to manage regulatory activities according to timelines, scope, budgets, and strategies • Ability to participate on multidisciplinary project teams • Subject matter expertise in regulatory activities and troubleshooting • Ability to prepare estimates for regulatory services proposals • Ability to support client meetings and business development activities • Knowledge of global regulatory requirements and company policies/processes • Ability to prepare training materials and share regulatory best practices • Ability to support internal or external project audits • Ability to contribute to SOPs and process documentation • Ability to provide oversight and guidance to team members • Ability to identify when line support is required • Maintenance of individual training records and completion of designated required training • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations for employees or applicants with disabilities

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