Regulatory affairs

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 

Must have experience in the Nutraceutical Industry. Good knowledge of FSSAI regulations, product registration & regulatory documentation.

The role holders effectively manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges (synthetics/biologics) to deliver the needs of both the AZ business and the customer. AstraZeneca

Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.

Coordinate with cross-functional teams, including Clinical, Quality, and Manufacturing, to gather necessary regulatory documentation.