Specialist RA

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

• Coordinate with internal (i.e. Execution team, API-RA, Plant, SCM, CPPK etc.) as well as external counterparts (i.e. external API manufacturing and testing sites etc.)
• Trigger request for all the administrative documents like foreign CPP, Indian CoPP / FSC / WHO GMP from respective CFT's and list down the open issues, also provide the document request to plant.
• To co-ordinate and understand the on-going review status of the product in the lead markets and update the API Plus project simultaneously demanding its review stage and tentative approval timeline.
• Draft deficiency responses, co-ordinate with CFTs, track the action items and review the documents for deficiency response.
• Display ability for timely response to deficiencies
• Demonstrate the ability to communicate the essential requirements to CFTs.
• Provide all the launch sheets and tech-packs, to facilitate timely launch of products. Support commercial team with tender related documents.
• Archive the submissions, responses, and other data in product folder.

Qualifications

M Pharm / Masters in science

Experience : 10 -15+ years

Handing the Customer Audits and MoH Audits at our Manufacturing sites.

Technical Skills

Behavioral Skills

Skills Required

Product Development, manufacturing processes , Good Manufacturing Practice, Quality Systems, Intellectual Property