Regulatory Affairs Analyst

  • Full-time
  • Job Family: Regulatory Affairs
  • Sub Job Family: Regulatory Affairs General
  • Preferred type of working: On-Premise
  • Business unit: IPDO
  • Years of Experience: 6 - 12

Company Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Description

  • Should have an experience in Europe market pre/post approval submissions
  • Evaluation of Europe post approval changes with precise classification and documentation.
  • Preparation, review and submission of variations and renewals for EU market
  • Timely interaction with overseas colleagues on updates/approvals
  • Handling of deficiencies and timely response to regulatory agencies
  • Good interpersonal skills with command on English language to communicate with Regulatory agencies & IL Customers
  • Providing regulatory guidance/regulatory strategies to IL partner and other cross functional teams
  • Support the manufacturing sites during Regulatory audits
  • Should have the sound knowledge on GMP/QMS/Plant operations

Qualifications

Master of Pharmacy

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