Director - Regulatory Affairs - Pharma

- Define solid RA strategy and plan based on deep understanding of the regulatory environment and business dynamics.

- Provide strategic guidance for product development and planning throughout the product lifecycle.

- Provide regulatory intelligence and manage internal process to share regulatory landscape change and drive needed attention and action from internal stakeholders. 

- 5 years senior RA leader experience in a well-established MNC life science company, prefer device related.

- Efficiently manage timelines (submissions to approval) to cope with regional and local projects & strategies as well as marketing plans through proactive communications with all relevant parties including country/region leader, RA, R&D, Marketing, Supply Chain, Sales and any other functions.

- Represent organization while responding to regulatory agencies- query and other correspondences after engaging and interacting with regulatory authority like state FDAs, CDSCO, FSSAI, Legal Metrology, etc. 

- It is important to establish and maintain good relationships with Regulatory authorities and industry associations, ensuring optimum visibility and smooth products registration