Regulatory affairs

Communicate with headquarter regulatory team on local regulation changes with impact assessment. Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.

The Manager, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle and ensures the smooth running of the Regulatory Affairs Department

Bachelors Degree in Pharmacy, Life Sciences, Biomedical Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related scientific discipline.

Degree in Chemistry, Biology, or related Life Sciences. Write CMC regulatory dossiers for Drug Substance filing, small and Large API Molecules using source documents, ensuring accuracy, completeness, and compliance.

To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.

Bachelors degree in Life Sciences, Engineering, Regulatory Affairs, or a related field; Master's degree preferred. 5+ years of experience in Regulatory Affairs, Regulatory Intelligence, Quality, Compliance, or related functions within the medical device or IVD industry.

As a Senior Manager – Regulatory Compliance, you will lead IT implementation projects in regulated GxP environments, leveraging your deep expertise in Regulatory Affairs and Regulatory Information Management Systems (RIMS) and strong consulting capabilities.

Bachelors degree in Regulatory Affairs, Science, Life Sciences, Healthcare. Author and maintain regulatory documentation including technical documentation, declarations, regulatory assessments, intended use statements, labeling reviews, and compliance records.

Regulatory Compliance Management. Product Registration & Lifecycle Management. Cross-Functional Stakeholder Management