Dr Reddys - Head - Regulatory

About Dr.Reddy- s

Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company. As a fully integrated pharmaceutical company, our purpose is to provide affordable and innovative medicines through our three core businesses: Pharmaceutical Services and Active Ingredients (PSAI), comprising our Active Pharmaceuticals and Custom Pharmaceuticals businesses. Global Generics, which includes branded and unbranded generics. Proprietary Products, which includes New Chemical Entities (NCEs), Differentiated Formulations, and Generic Biopharmaceuticals.

Our products are marketed globally, with a focus on India, US, Europe and Russia. Our strong portfolio of businesses, geographies and products gives us an edge in an increasingly competitive global market and allows us to provide affordable medication to people across the world, regardless of geographic and socioeconomic barriers. We have over 14000 employees working pan India and over 3000 abroad. For more details pl visit us at www.drreddys.com.

About the Role

As part of business development, Dr. Reddy's is trying to foray into new countries like Japan. We are looking for a senior professional to lead the efforts in this direction by providing necessary support for product filing and launch.

Purpose

To enable Dr. Reddy's entry in Japan through seamless execution and bridging of Regulatory, Statutory and Commercial aspects of product filings / regulatory compliance in Japan

Job Description / Roles and Responsibilities

1.Regulatory Support:

- Scientific Document support for PMDA(Equivalent to USFDA at Japan) meetings

- Gap analysis from regulatory consultants - dissemination to relevant stakeholders

- Execution of gaps and ensure dossier readiness

2.Connect with Product Development teams and leverage

- Ensure current filing (US/EU) to be leveraged for Japan for selected product

- Ensure API, excipients, packaging material and analytical requirements are timely reviewed and met

- Evaluate filed products for leverage and identify issues to ensure timely filing by liaising with the PMO for OSD and Injectables

3.Connect with Product Manufacturing teams and leverage

- Work with quality and manufacturing groups on making manufacturing sites ready for PMDA

- MAH filing and related liaising with PMDA/MHLW

- Participate in Japan specific plant audits - mock and PMDA

4.Organization Development: Establish long term know-how of the market from technical/regulatory requirements. Also disseminate this knowledge to functional groups in development and manufacturing

5.Statutory: Perform all obligations w.r.t. MAH readiness, entity creation and all licenses necessary for commercial operations.

Key Performance Indicators

Timely filings as agreed with business head

Timely inputs for Leverage decisions

Manufacturing Readiness for Japan