Job Description:

Job Summary

The Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all regulatory activities are aligned in a timely and productive manner.

Markets: India.

CORE JOB RESPONSIBILITIES:

Regulatory Affairs Support:
Developing the regulatory strategy including Filling readiness of NDA’s & sNDA.
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 current 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.

Business Support
Responsible independently current product regulatory strategy discussion with area regulatory, responsible collaboration with commercial team for launch plan, managing product lifecycle maintenance activities viz variation submissions, labelling updates, renewals, testing of samples as per stipulated timelines and in line with company and Health Authorit

📌 Regulatory Affairs Bengaluru (India)
🏢 MM Staffing & Career Consultants
📍 India