Regulatory Affairs Jobs in Hyderabad

Job Summary We are seeking an experienced Analytical Specialist specializing in Mass Spectrometry to develop sensitive and robust methods for quantifying genotoxic impurities in drug substances and products. This role involves method development validation troubleshooting and resolving method-relate...

Im looking for a Regulatory Affairs Specialist to oversee the preparation and submission of regulatory dossiers ensuring compliance and timely approvals. This role is pivotal in managing activities pertaining to product lifecycle management quality management and pharmacovigilance including variatio...

Role SummaryThe PAT Specialist (PhD) will contribute to the development implementation and lifecycle management of advanced Process Analytical Technology solutions across peptide oligonucleotide small-molecule and drug-product manufacturing processes. This role combines scientific depth hands-on PAT...

Job SummaryWe are seeking a skilled enthusiastic and experienced Scientist to join our Immunogenicity team. This role focuses on supporting Immunogenicity Risk Assessment for complex generics and differentiated products spanning strategy development and product approval across diverse therapeutic ar...

Author and/or participate in preparation of Design History File (ISO 13485) and Risk Management (ISO 14971) for drug-device combination products such as prefilled syringes autoinjectors pen injectorsSupport preparation of technical package for Notified Body Opinion submissionsPreparation and executi...

About MasterControl:MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organ...

Location: Hyderabad IndiaDepartment: Regulatory AffairsReporting to: MDExperience: 15–25 years in Regulatory Affairs (Injectables ROW markets; strong exposure to 505(b)(2) preferred)Role SummaryThe Regulatory Affairs Head – ROW Market will be responsible for leading and managing all regulatory submi...

About MasterControl:MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organ...

Job Summary We are seeking a dynamic and experienced Specialist in Process Development - API in the pharmaceutical development process responsible for strategy evaluations process design optimization scale-up.Roles & Responsibilities You will be responsible to Conduct strategy evaluations to design...

This role will be responsible for:Collaborate with business leaders and HR partners to identify learning and development needs and develop solutions that drive business results.Design program manage and evaluate impactful learning solutions that are aligned with business needs and goals leveraging a...

Job Description: Business Development Associate Global Staffing Services About Us:Inductive Quotient Analytics (IQA) is a global Full-Service CRO and ClinTech company delivering end-to-end solutions across the clinical trial life cycle. With presence in India the U.S. and Japan and collaborations a...

Job Summary We are seeking a dynamic and experienced person in Process Development Plan and execute process optimization trials & to execute scale up/ confirmatory batch and to support pilot batch exhibit batches by applying various engineering concepts during optimization and scale up.Roles & Respo...

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunitie...

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 a...

Job Summary Role SummaryThe Process Engineer PAT will lead and support the design deployment and lifecycle management of PAT solutions across peptide oligonucleotide and small-molecule drug product manufacturing platforms with a special focus on organic synthesis crystallization and formulation ope...

Job SummaryWe are seeking a dynamic and experienced Specialist in Biopharmaceutical team to provide strategic guidance and oversight for product selection and development across global markets. This role requires a strong understanding of bio-complexity assessment regulatory compliance and risk mana...

Job Summary We are seeking a dynamic and experienced Specialist in Process Development - API in the pharmaceutical development process responsible for strategy evaluations process design optimization scale-up.Roles & Responsibilities You will be responsible to Conduct strategy evaluations to design...

Job Summary We are seeking a dynamic and experienced Analytical Scientist in Microbiology to design and execute experiments analyse and interpret data and report the results. Able to maintain laboratory equipment troubleshoot instrumentation and ensure accurate record keeping. And maintain the safet...

Job Summary We are seeking a dynamic and experienced Scientist in Process Engineering in Active Pharmaceutical Ingredient (API) development with proven expertise in scaling up or down technologies to meet production demands. Proficient in Process and Chemical Engineering adept at troubleshooting com...

Job Summary We are seeking a dynamic and experienced Specialist in Process Development in the pharmaceutical development process responsible for strategy evaluations process design optimization scale-up calculations and handling exhibit batches. This role involves working on oral solid formulations...