Regulatory Affairs Manager

Role Description

This is a full-time on-site role for a Regulatory Affairs Manager based in Mumbai. The primary responsibilities include ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining the organization's quality systems. The role also involves monitoring updates to regulations and advising internal teams to ensure adherence to compliance standards.

Qualifications

• Strong understanding of Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
• Experience handling Regulatory Submissions and associated processes
• Prior experience in regulatory affairs or compliance-related roles, preferably in the pharmaceutical or healthcare industry
• Applications for COPP, Product Permission, FSC and renew any required permits and licenses.
• Follow instructions of superiors for completion of work.
• Co-Ordination with clients for ongoing dossier documentation and samples.
• Monitoring quality standards are met, and submissions meet strict deadlines.
• Checking for the artwork, literature as per guideline.
• Co-Ordination with plant for registration documents and sample follow-up.
• Handling MOH or clients query related to documentation
• Document generation for assigned countries as per requirements.
• Assign training to subordinates/Jr. Exe.
• Dossier Preparation and Review
• Co-ordinate with external agency for the requirement of DMF, BA/BE, CDP and other related documents.
• Plant visit for document/sample arrangement and during audit.
• Courier samples, dossiers locally or internationally.