Regulatory Affairs Job at Syneos Health | MPharm Graduates Apply Now for the Associate Role
Syneos Health is seeking an Associate in Regulatory Affairs (Module 3, CMC) to manage post-approval CMC submissions, IND filings, and lifecycle maintenance activities. This Regulatory Affairs Job at Syneos offers the opportunity to work with a global biopharmaceutical solutions organization, collaborating on regulatory compliance, project management, and documentation across multiple therapeutic areas.
- Job Post: Associate in Regulatory Affairs
- Locations: Remote, Hybrid – Gurugram, India
- Job Requisition ID: 25100545
About Syneos Health:
Syneos Health is a fully integrated biopharmaceutical solutions organization that accelerates customer success through clinical development, medical affairs, and commercial insights. The company values career development, inclusive culture, and innovation across 110 countries.
Job Responsibilities:
- Prepare Module 3 sections for post-approval CMC variations, renewals, annual reports, legal entity changes, and other lifecycle maintenance activities.
- Prepare and submit full or partial IND, marketing, and lifecycle maintenance applications in compliance with government regulations.
- Utilize Veeva RIMS for submission content planning and objectives creation (preferred).
- Process information with high reliability, accuracy, and adherence to standard operating procedures.
- Undertake project-specific activities independently or under supervision, within timelines and budget.
- Maintain regulatory databases, records, and logs as per Syneos Health or client requirements.
- Conduct quality control reviews of documents, track submissions, and deliverables to clients.
- Attend client meetings, support projects, and build strong client relationships.
- Monitor workload, identify risks to project delivery, and escalate issues as required.
- Assist in training and mentoring team members, maintaining individual training records.
Qualifications:
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Education: MS/M.Pharm or equivalent combination of education and experience.
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Experience: Minimum 6 months for Regulatory Associate; 1.5 years for Senior Regulatory Associate.
Skills Required for the Syneos Career:
- Strong analytical and documentation skills.
- Proficiency in Microsoft Office applications.
- Experience with RIM systems (Veeva RIMS, Trackwise) preferred.
- Ability to work independently and follow detailed instructions.
- Excellent interpersonal and communication skills in English.
Why Syneos Career?
- Opportunity to work with a leading global biopharma solutions company.
- Career growth through training, mentorship, and diverse project exposure.
- Inclusive, supportive culture promoting Total Self and belonging.
- Experience with high-impact projects including FDA-approved drugs, EMA-authorized products, and global clinical trials.
