DRA

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.

Review QMS documents, SOPs, processes and records for compliance with GMP requirements; Support OOS, OOT, deviations, change controls, CAPA, risk assessments and investigations; Ensure compliance with ALCOA+ data integrity principles

Liaise with Global Regulatory Affairs, Medical, Clinical and Pharmacovigilance teams to obtain required documentation and ensure successful submissions.

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.

Cross-Functional Collaboration: Work closely with Regulatory, International Export, Marketing, and R&D teams to streamline the flow of information and ensure project alignment.

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.