Regulatory Affair Analyst

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 Summary
We are seeking for a detail-oriented Regulatory Affair analyst  to join our team in Hyderabad, India. In this role, you will play a crucial part in ensuring our organization's compliance with regulatory requirements and strategies.

Roles & Responsibilities

• Prepare  regulatory dossiers for submissions for pharmaceutical or medical device products for CN and TW Mkts
• Implement regulatory guidelines and requirements to ensure compliance during New Product development /Leverage , Filing , Approval and Launch
• Assist in the development and implementation of regulatory strategies for new and existing products
• Connect and Collaborate with CFTs including manufacturing sites / CMOs / ILOS partners, reviewing the various plant documents, coordinating with Country team for dossier preparation clarifications 
• Listing the open points during filing and ensuring the responses are made ready before deficiency is received
• Understanding the deficiency and preparation of deficiency response by coordinating with CFT's in time
• Understand and interpret changes /new guidance's that evolve at CDE and evaluate the impact on existing or upcoming products pipeline Communicate the updates to relevant stakeholders
• Coordinating with the NPL  team and identifying the right time for variation filing to ensure that the supplies would not get disturbed
• Maintain accurate and appropriate archival of regulatory information through databases and Documentation
• Participate in regulatory agency inspections and audits as needed
• Contribute to the continuous improvement of regulatory processes and procedures

• Qualification : M Pharm ; Years of Experience : 4 to 6 years
  Mandatory Skills : Knowledge on Pharmaceutical Development Development ; FDA, NMPA and EMA guidelines, Good Communication Skills (Written, Oral, and Presentation)
• Proficiency in regulatory documentation and technical writing
• Understanding of compliance management principles
• Proficient in Microsoft Office Suite and regulatory information management systems
• Ability to work effectively in a fast-paced, dynamic environment
• Willingness to travel occasionally for regulatory inspections or meetings/Training programs 

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/