Global Calcium Pvt Ltd
Are you an experienced regulatory professional looking for an opportunity to contribute to global pharmaceutical compliance? Global Calcium, a leading pharmaceutical manufacturer, is seeking a Manager – Regulatory Affairs to join our dynamic team. This role is ideal for professionals with a strong background in DMF & CEP filings and global regulatory submissions.
Manager – Regulatory Affairs
📍 Location: Hosur (20 mins drive from E.City Bangalore and 10 mins drive from Attibele)
📂 Department: Regulatory Affairs
📅 Experience: 10-15 Years
Global Calcium is looking for an experienced Manager – Regulatory Affairs with expertise in DMF & CEP filings and global regulatory submissions. If you have a passion for ensuring regulatory compliance and working with global health authorities, we want to hear from you!
Key Responsibilities:
✅ DMF & CEP Filings: Prepare, review, and submit Drug Master Files (DMFs) in eCTD/NeeS format for USFDA, EU, and other markets. Handle amendments, annual updates, and regulatory deficiency responses.
✅ Regulatory Submissions & Compliance: Collaborate with R&D, Quality, and Manufacturing teams to compile technical data while ensuring adherence to GDP & global regulatory guidelines.
✅ Regulatory Communication & Strategy: Act as a liaison with regulatory authorities (USFDA, EU-GMP, TGA, etc.) and provide guidance on compliance strategies.
✅ Audits & Documentation: Support regulatory inspections & audits, ensure all regulatory documents are updated, and train internal teams on submission processes.
Qualifications & Skills:
🎓 Education: M.Pharm / B.Pharm / M.Sc. in Pharmaceutical Sciences, Regulatory Affairs, or Chemistry.
📌 Experience: 10+ years in Regulatory Affairs, with expertise in DMF & CEP filings.
🔍 Key Skills: Regulatory guidelines, documentation, stakeholder management, analytical thinking, and communication skills.
About Global Calcium
Global Calcium is a renowned pharmaceutical company known for its commitment to regulatory excellence and high-quality products. With a strong presence in international markets, we are dedicated to maintaining compliance with global health authorities.
Why Join Us?
🌍 Work in a globally recognized organization in the pharmaceutical industry.
📈 Contribute to key regulatory approvals across international markets.
🤝 Collaborate with a team of experts in a dynamic environment.
How to Apply
If you are passionate about regulatory compliance and want to make a global impact, we would love to hear from you! 📩 Send your resume to: [email protected]
🔄 Know someone who might be a great fit? Share this opportunity!
To apply for this job email your details to ramakrishnar.r@globalcalciumpharma.com.
