Amarant Lifesciences Pvt. Ltd. is hiring Executive / Senior Executive / Specialist – Regulatory Affairs in Noida, Uttar Pradesh. This Regulatory Affairs job offers an exciting opportunity for professionals with hands-on experience in US FDA and Health Canada submissions, CTD/eCTD dossier preparation, and regulatory lifecycle management.
If you have 2–6 years of experience in pharmaceutical regulatory affairs and are looking to strengthen your global market exposure, this Regulatory Affairs Executive role could be your next career move.
📌 Job Overview
- Position: Executive / Senior Executive / Specialist – Regulatory Affairs
- Location: Noida, Uttar Pradesh, India
- Job Type: Full-Time (On-site)
- Experience: 2–6 Years
- Markets: US & Canada (US FDA & Health Canada)
This Regulatory Affairs job focuses on managing regulatory submissions and lifecycle activities for North American markets while ensuring compliance with global regulatory standards.
🎯 Key Responsibilities
As a Regulatory Affairs Executive, your responsibilities will include:
- Preparation, review, and submission of CTD/eCTD dossiers to US FDA and Health Canada
- Managing post-approval submissions such as supplements, amendments, and annual reports
- Preparing controlled correspondences and scientific advice packages
- Evaluating regulatory impact of variations, deviations, and change controls
- Maintaining regulatory databases and submission tracking systems
- Coordinating with cross-functional teams for submission documentation
- Ensuring audit and inspection readiness
- Supporting CAPA activities during regulatory inspections
- Staying updated with evolving US FDA and Health Canada guidelines
This role demands strong expertise in regulatory compliance, documentation control, and lifecycle management in the pharmaceutical industry.
🎓 Qualifications & Eligibility
Candidates applying for this Regulatory Affairs Executive job must meet the following criteria:
Education:
- Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, Biology, or related Science field
- Master’s or PhD preferred
Experience:
- 2–6 years of Regulatory Affairs experience in pharma/biotech
- Hands-on exposure to US FDA and Health Canada submissions
- Strong knowledge of CTD/eCTD publishing and lifecycle management
Skills Required:
- Regulatory compliance & documentation expertise
- Experience with regulatory databases/software tools
- Excellent communication & organizational skills
- Inspection readiness and audit support knowledge
💼 Why Consider This Regulatory Affairs Role?
- Exposure to global regulatory markets (US & Canada)
- Strong career growth in regulatory lifecycle management
- Opportunity to work on CTD/eCTD submissions for major markets
- Direct involvement in audit & inspection preparedness
- Collaborative cross-functional regulatory strategy work
For professionals targeting senior Regulatory Affairs positions in multinational pharmaceutical environments, this role provides valuable North American regulatory exposure.
📧 How to Apply?
Interested and eligible candidates can share their updated résumé at:
Ensure your CV highlights:
- US FDA submission experience
- Health Canada dossier handling
- CTD/eCTD lifecycle expertise
- Audit/inspection exposure
