Manager - Regulatory Affairs

- Developing the regulatory strategy including Filling readiness of NDA's & NDA.

- Responsible for ongoing renewals, variations and maintenance of registered products and CDx (devices).

- Collaborating with global teams during early stage of product development and share the inputs on regulatory requirements from development and data perspective.

- Understand timelines of the availability of various documents for filling application and supply chain of the new product for which regulatory strategy is been created.

- Understand likely queries and keep documents ready in advance to either share the same to prevent the query or to have short lead time in submitting query response.

- Maintain an awareness of country's regulatory legislation.

- Monitor progress of marketing applications through the regulatory system.

- Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.

- Monitor SEC recommendation and CTRI on Reg Intel information on the registration.

- Contribute in Regulatory Policy related matters by providing inputs for draft guidelines / Regulations.