Are you ready to take your career to the next level in global pharmaceutical regulatory affairs? Novumgen, an innovation-driven and rapidly expanding pharmaceutical company, is hiring a Regulatory Affairs Executive in Ahmedabad. This is your opportunity to be part of a global team that ensures compliance, quality, and scientific excellence across regulated markets.
At Novumgen, our regulatory success speaks for itself:
✅ 200+ Ready Dossiers
✅ 60+ eCTD Submissions
✅ 100+ CTD Dossiers
✅ 70+ ACTD Submissions
✅ 100+ Regulatory Findings
Join a company where your expertise can truly make a difference in healthcare.
Key Responsibilities
- Coordinate with cross-functional teams including Development, Clinical, Nonclinical, Pharmacovigilance, Quality, and Manufacturing.
- Review and consolidate technical and scientific documentation to ensure accuracy, consistency, and regulatory compliance.
- Draft and review high-quality responses to UK/EU agency queries related to quality, safety, and efficacy.
- Ensure all submissions comply with global regulatory standards such as MHRA, EU, and ICH guidelines.
- Maintain eCTD formatting and proper referencing across dossiers.
- Adhere to internal quality systems, documentation protocols, and SOPs.
Required Qualifications & Skills
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm).
- At least 2 years of experience in Regulatory Affairs, preferably focused on the UK/EU region.
- Strong understanding of global regulatory frameworks.
- Excellent coordination, communication, and documentation skills.
- Detail-oriented with the ability to manage multiple submissions simultaneously.
Why Join Novumgen?
- Be part of a global company expanding across regulated and semi-regulated markets.
- Gain hands-on exposure to complex global submissions and eCTD systems.
- Collaborate with a team of scientific and regulatory experts.
- Competitive salary and growth-oriented environment.
💰 Salary: ₹5,00,000 – ₹8,00,000 per annum (based on experience)
How to Apply
Interested candidates can share their updated CVs to:
📩 isha.patel@novumgen.com
🌐 www.novumgen.com
About Novumgen
Novumgen is a UK-based global pharmaceutical company dedicated to innovation, quality, and accessibility. With a strong portfolio of generics and specialty pharmaceuticals, Novumgen operates across multiple therapeutic areas, delivering reliable and affordable healthcare solutions worldwide.
FAQs
Q1. What experience is required for the Regulatory Affairs Executive role at Novumgen?
Candidates should have at least 2 years of experience in Regulatory Affairs, preferably with exposure to UK/EU submissions.
Q2. Where is this job based?
The position is based in Ahmedabad, Gujarat, India.
