Regulatory Affairs Associate

Company DescriptionDr 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 transparencyDr 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 an individual to carry out core regulatory activities including dossier finalization filing regulatory applications internal liaison for regulatory information compilation coordination with Quality Assurance teams during audits and ensuring regulatory compliance and systems Roles Responsibilities You will be responsible for the finalization of dossiers including drafting compilation archival and following systems and SOPs Standard Operating Procedure related to dossier management You will execute the filing of study applications toxicity studies clinical studies marketing authorizations manage administrative requirements for filing handle query responses process specific permissions at the Ministry of Science and Technology and the Ministry of Health such as licenses of import export test commercial or permits You will be an internal liaison for compilation of regulatory information for dossiers and query responses working closely with CMC Chemistry Manufacturing and Controls NC Non-Clinical and clinical SMEs Subject Matter Experts to collect and transact information necessary for compilation You will be responsible for coordinating with Quality Assurance teams during audits actively participating in audits to transact regulatory information that supports facility inspections Your responsibilities include executing IBSC Institutional Biosafety Committee activities and reporting compliance to the Ministry of Science and Technology and drafting and implementing SOPs for key regulatory processes You will be responsible for drafting and compiling regulatory compliance correspondences as per country regulations particularly related to CMC APQR s - Annual Product Quality Reviews PAC s - Post Approval Changes Clinical Phase 4 PSUR s - Periodic Safety Update Reports PIL s - Patient Information Leaflets IB s - Investigator s Brochures compensation reports etc You will be involved in designing customizing and maintaining regulatory information systems such as SharePoint Electronic Common Technical Document eCTD and Document Management System DMS QualificationsEducational qualification A Master s degree in any of the life sciences Microbiology Biochemistry Biotechnology Bioinformatics Immunology regulatory affairs pharmacy etc Bachelor s will be considered if there is sufficient prior experienceMinimum work experience 2 years of experience in regulatory affairs total 6 years biologics biosimilar research and development is good to haveSkills attributes Technical Skills Ability to stay up-to-date with business priorities and a skill to calibrate strategies against the changing dynamics of the business environment Good understanding of Information Technology IT platforms supporting regulatory activities including eCTD DMS and Regulatory Information Management System RIMS Knack for analysing regulatory information to identify risks demonstrating the ability to assess regulatory data critically and identify potential challenges or areas of concern Behavioural skills Possesses strong negotiation skills cultural sensitivity and excellent interpersonal skills Pays meticulous attention to details in tasks and responsibilities Effectively manages and responds to ad hoc priorities that arise due to requests from the Ministry of Health MOH Demonstrates a commitment to continuous learning and staying updated on the latest regulatory expectations Additional InformationAbout the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon With a robust portfolio of biosimilar products across key therapeutic areas covering US 80 Bn in innovator sales - future business pipeline covers a variety of product classes and therapy areas and new modalities Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products With a Product Development engine that has end-to-end capabilities - in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900 000 patients having benefited from our products till date 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