Regulatory Affairs Specialist

Job Description

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: 08+ years in Regulatory Affairs, with expertise in DMF & CEP filings. Key Skills: Regulatory guidelines, documentation, stakeholder management, analytical thinking, and communication skills. 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. Interested candidates can send their resumes to: ramakrishnar.r@globalcalciumpharma.com Know someone who might be a great fit? Share this opportunity!