Syneos Health require Senior Regulatory Associate - M.Pharm, MSc Apply

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Post : Sr Regulatory Associate (CMC)

Job Description
Primary :
• Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA)
• Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.
• Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.
• Can support change control assessment and impact assessments for global markets.
• Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.
• Assists in training and mentoring of team members depending upon project requirements
• Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.
• Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.
• Timely sensitization /escalation within team to maintain compliance and adherence to timelines.

Secondary :
• Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.
• Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases
• Hands on experience of RIMS/VEEVA vault.
• Excellent written and verbal communication skills
• Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs
• Good communication skills - clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings

Candidate Profile
• Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.
• Ability to work independently and manage multiple priorities in a fast-paced consulting environment.
• Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment
• Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance

Additional Information
Experience : Minimum 4 years
Qualification : M.Pharm, M.Sc
Location : Gurugram-Hybrid
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 25003846-7
End Date : 30th June 2025