Analyst Regulatory Affair

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 Summary We are seeking a detail-oriented Analyst in Regulatory Affairs to oversee Emerging Markets procedures - ANZ handle Marketing Authorization Application and ensure compliance with regulatory guidelines Responsibilities include managing chemistry manufacturing and controls CMC documentation addressing deficiency letters contributing to regulatory strategy development and facilitating effective communication with stakeholders for successful product launches and regulatory compliance Roles Responsibilities You will be responsible for handling the end-to-end various Registration in ANZ and EM You will be responsible for preparation review and submission of Dossier in ANZ and Emerging Markets as per the applicable regulatory guidance in Emerging Markets You will be responsible authoring high-quality chemistry manufacturing and controls CMC documentation for health authorities submissions applying agreed CMC global regulatory strategies assuring technical congruency and regulatory compliance throughout the project lifecycle You will be responsible to review of critical quality regulatory documents like specifications stability protocols stability data development report justification reports etc You will be responsible for on time Response to deficiency letters You will be responsible for preparing Regulatory strategy notes regulatory due diligence and gap analysis for leverage products Evaluating and sharing the Regulatory Affair requirements with product development teams at the product introduction stage performing regulatory due diligence and consolidated gap analysis for leveraging You will be responsible for identifying all open issues and anticipated questions on regulatory submission at respective stage of product development Dossier filing and deficiency responses in consultation with team leads You will be responsible to review and closure of change control notifications CRNs for under development under review and launch products in consultation with team lead You will be providing launch support w r t key regulatory decisions You will be responsible to interact with Internal and External stakeholders customers and provide timely regulatory guidance on various issues Qualifications Educational qualification M Pharm Minimum work experience 4-6 years of experience in ANZ Regulatory affairs Skills attributes Technical Skills Knowledge on Regulatory requirements Understanding of product development manufacturing processes Intellectual Property and quality Experience in GxP documentation Behavioral Skills Excellent communication and interpersonal skills Efficient and a good collaborator Effective planning and high level of performance orientation Strong analytical and problem-solving abilities Additional Information 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