Analyst Regulatory Affairs

3 weeks ago

Hyderabad Telangana, India Dr. Reddy's Laboratories Full time

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 Preparation review of US ANDAs 505 b 2 EU Canada dossiers for Parenteral products as per regulatory requirements Preparation review of deficiency responses regulatory strategy note controlled correspondences Briefing books labeling artworks and ScA meeting packages Coordinate with internal stake holders R D AR D SCM FTO CTO etc and external counterparts CMO CRO to review regulatory documents and proposals and provide strategic inputs Identify all open issues at product development ANDA filing and deficiency responses in consultation with team lead RA vertical head Provide support to commercial launch team w r t review progress and evaluate changes proposed for commercial batches batch records specifications analytical method Stability protocols PVPs etc In coordination with eCTD labeling team ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines Qualifications M Pharm M Sc OR PhD Additional Information Good communication skill Written and Oral Self-starter with a go-getter attitude and team player Quick learner and able to prioritize information Good interpersonal skills High level of proficiency in networking internally and externally

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