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 Positive 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 looking for a dynamic and experienced Scientist to join our Pre-clinical team This role supports the cross functional teams in product introduction nonclinical development of generics complex generics and differentiated products from strategy and development to product approval across all verticals and global markets Roles Responsibilities You will be responsible for Preparation of Toxicological Risk Assessments Permissible Daily Exposure and Occupational Exposure Limit monographs Tox risk assessments for excipients impurities extractable leachables You will be responding to queries regarding toxicological hazards from various cross functional teams and supporting Lead Expert in problem solving of queries from the Safety Plant teams in providing toxicological hazard information for Actives intermediates KSMs You will responsible for supporting Lead Expert in solving queries pre-clinical strategy for complex generics and Preclinical Non-clinical in-vitro in-vivo study designs You will be supporting Lead Expert for Pre-clinical CRO qualification performing GLP Non-GLP study audits study monitoring review of Non-Clinical study protocols reports and data analysis You will be required to continuously gather and analyse peer-reviewed literature regulatory guidelines and scientific reports related to Pre-clinical models Tox risk assessments contributing to team discussions and decision-making You will collaborating with internal teams and external stakeholders to provide toxicological assessments study support to ensure alignment with project goals and regulatory requirements You will be Responsible to prepare Maintain and adhere to SOPs Qualifications Educational qualification Master s Degree M V Sc M Pharm Pharmacology Minimum work experience 5-6 -Years experience in Pharma Industry in Pre-clinical Toxicology risk assessments Skills attributes Technical Skills Preparation of Toxicological Risk Assessments Permissible Daily Exposure and Occupational Exposure Limit monographs Experience in Performing Extensive Literature search Able to understand analyze physico-chimeical clinical non-clinical data identify data gaps Relevant experience in determining relevant toxicological hazards for the actives intermediates KSMs Experience in Toxicological Risk assessment methodologies Experience in drafting PDE and OEL monographs Experience in Pharmaceutical impurity E L and environmental risk assessments Knowledge on relevant EMEA FDA ICH ISO ASTM guidelines Knowledge on biocompatibility evaluation requirements and Medical Device regulations is desirable Knowledge on using QSAR tools BMDS and MPPD software Preclinical strategy Experience in Preclinical drug development Knowledge on Preclinical Regulatory requirements for ANDA NDA filings Ability provide preclinical strategy and study design Experience in interacting with regulatory authorities is desirable Providing operational support for non-clinical study conduct Knowledge of GLP OECD guidelines pertaining to toxicity study conduct Ability to support colleagues for critical operational activities of nonclinical study Tox PK TD execution at CRO s Ability to QC check Review of toxicity study protocols data reports Should be able to compile study findings for internal discussion and decision making Should be able to perform QC check Review the in life and terminal parameter data Perform statistical analysis of study data Behavioural Skills Excellent communication and interpersonal skills Strong analytical and problem-solving abilities Ability to work collaboratively with own team and cross-functional teams Ability to multi-task prioritise and deliver effectively under stringent timelines Additional Information About the Department Integrated Product Development Organization 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 Dr Reddy s fosters career growth through personalized learning programs and industry-leading benefits including relocation support family benefits medical and life coverage and professional development opportunities Our Work Culture At Dr Reddy s we come to work every day because Good Health Can t Wait This is our 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