Associate Regulatory Affairs (Module 3, CMC) – Remote India
Location: Remote – India
Salary: Competitive industry-standard package, typically ₹4,50,000 – ₹7,00,000 per annum based on experience
Syneos Health is hiring for an Associate Regulatory Affairs (Module 3, CMC) role. This is a remote opportunity in India, offering competitive pay and excellent career progression. Apply now to join a global leader in clinical research and pharmaceutical innovation. Work with an organization that has contributed to 94% of FDA-approved novel drugs in the past five years and 95% of EMA-authorized products.
This position involves preparing and submitting regulatory documents for post-approval CMC variations, renewals, and lifecycle maintenance activities, ensuring compliance with international regulatory standards. Candidates with expertise in RIM systems such as Veeva RIMS and strong knowledge of CMC requirements are encouraged to apply.
Responsibilities:
Prepare Module 3 sections for CMC variations, renewals, annual reports, and lifecycle maintenance.
Submit IND, marketing, and maintenance applications according to global regulations.
Work in Veeva RIMS to create objectives and submission content plans.
Process information accurately and meet strict deadlines.
Maintain regulatory databases and records as per client requirements.
Conduct QC reviews of documents, track submissions, and liaise with clients.
Mentor and train team members when required.
Identify risks to project timelines and propose solutions.
Complete all mandatory training and maintain updated records.
Required Skills & Qualifications:
MS/M.Pharm or equivalent education.
6 months experience for Regulatory Associate; 1.5 years for Sr. Regulatory Associate.
Knowledge of CMC regulations and global submission standards.
Advanced MS Office skills.
Preferred experience with RIM systems (Veeva RIMS, Trackwise).
Strong analytical, communication, and multitasking abilities.
Fluent in written and spoken English.
Perks & Benefits:
Competitive salary and performance bonuses.
Career development and therapeutic area training.
Recognition programs and supportive management.
Opportunity to work on global pharmaceutical projects.
About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions provider operating in over 110 countries with 29,000 employees. We partner with pharmaceutical and biotech companies to accelerate the delivery of life-changing therapies through clinical research, regulatory affairs, and commercialization solutions.
Work Mode: Remote – India
Join Syneos Health and help bring transformative therapies to market faster. Apply today and advance your regulatory career with a global leader.
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