2122 Regulatory Affairs Jobs - Page 33

About The Role We are seeking a detail-oriented and proactive Data Quality & Configuration Analyst to support and enhance our ERP , SAP , and ITSM systems. The ideal candidate will be responsible for managing data quality , BOM configuration , and ensuring compliance with regulatory frameworks and internal controls . This role involves close collaboration with IT support , logistics , production control , and quality management teams. Key Responsibilities: Maintain and improve data quality standards across ERP and SAP systems. Configure and manage BOM (Bill of Materials) and master data in alignment with business and regulatory requirements. Support SAP parameterization , SAP support , and S...

We are looking for a skilled E-commerce Operations Manager to join our team at CSTE International, with 3-8 years of experience in the IT Services & Consulting industry. Roles and Responsibility Manage and oversee e-commerce operations for smooth and efficient functioning. Develop and implement strategies to enhance customer satisfaction and loyalty. Collaborate with cross-functional teams to achieve business objectives. Analyze market trends and competitor activity to identify growth opportunities. Ensure compliance with regulatory requirements and industry standards. Lead and motivate a team to achieve operational excellence. Job Requirements Proven experience in e-commerce operations mana...

Role & responsibilities The Assistant Manager Regulatory Affairs will manage regulatory activities related to the manufacturing and global supply of pharmaceutical excipients, ensuring compliance with Indian regulations (Schedule M, Drugs & Cosmetics Act) and support for international registrations and customer requirements. The role also includes support for compliance with Food Regulations. Key Responsibilities: Regulatory Affairs India - Prepare and submit applications for Drug Manufacturing Licenses, site approvals, and product-related permissions to State FDA/CDSCO - Ensure full compliance with Schedule M (GMP) requirements for excipient manufacturing - Handle site master files, SOPs, v...

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

The ideal candidate will bring in-depth experience in pharma warehouse operations, with a proven track record of managing large-scale warehouse functions efficiently.

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbei...

We are hiring Research Officer/ Research Executive at our R&D (Preferably Male Candidate) Location: Navi Mumbai Job Responsibilities: Analytical Method Development and validation of Assay, Dissolution and Organic impurity by using HPLC. Chemical Analysis raw material / finished product. Qualifications, Calibration of all instruments and Equipments as and when required. Method transfer to plant. Monitoring and Maintaining of GLP, GDP & compliance to audit points. Support and coordination for activity related to Project and Lab responsibility. Coordination with service engineers for instrument and equipment maintenance and trouble shooting. Support for training to juniors & new joiner. Keeping...

Required an exp HR & IR professional with strong exposure in compliance, payroll & industrial relations. Must be well-versed in local language & labor law Statutory Compliance & Labor Law Adherence Payroll Time Office MGT Employee Relations & Welfare Required Candidate profile 12–18yrs of HR & IR exp in manufacturing setup Excellent knowledge of Indian labor laws and statutory compliance Proficiency in local languages (Telugu for Hyderabad, Konkani/Hindi for Goa) preferred

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma i...

We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in ...

The Regulatory Compliance Manager position is a full-time role based in Delhi, India. As the Regulatory Compliance Manager, you will be responsible for ensuring the company's compliance with SEZ, Custom (MOOWR, AEO, SVB), DGFT, and FSSAI regulations. Your daily tasks will involve obtaining permissions from Custom authorities, implementing compliance mechanisms for MOOWR and AEO, and liaising with Custom and SEZ authorities to secure timely permissions for Laureate's clients. To excel in this role, you should possess a strong understanding of regulatory compliance and requirements, particularly in Custom and SEZ compliances. You will need to obtain various permissions from DGFT authorities fo...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is structured into two primary segments: Specialty Pharmaceuticals and Generics & APIs. Under Specialty Pharmaceuticals, the company specializes in Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. The Generics & APIs segment focuses on Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) serves as a wholly-owned subsidiary of Jubilant Pharma with Research & Development units located in Noida and Mysore, India. JGL operates manufacturing facili...

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as deliver...

You will be responsible for extending the global reach of the company through expert discovery and exploration of new and untapped business opportunities and relationships. As an International Business Developer, your primary role will involve finding and retaining clients, encouraging existing clients to purchase additional products or features, and staying informed about changes in consumption trends. Your key responsibilities will include performing business development activities in the pharma or Medical Device domain, demonstrating the ability to source leads from the international marketplace, generating leads, converting them into projects, and possessing experience in international b...

The Regulatory Affairs Associate is a project manager responsible for the RA lifecycle management on Medis dossiers for Teva's 3rd party client business (Medis), ensuring that information flow and provision of supportive documents reach the clients. The PM is responsible for liaising with Teva's 3rd party client business (Medis) supply chain, Teva site RA, and other relevant functions. In this role, you will be responsible for lifecycle management on specific products for Europe and the international market. You will ensure that regulatory modules under your responsibility are up to date and in accordance with agreed procedures. You will inform, prepare, and submit variations either directly...

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. Our business is organized into two segments - Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, has Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The Mysore manufacturing site, spread over 69 acres, is a USFDA approved facility producing APIs for global sales, with a focus on Lifestyle driven Therapeutic Areas like CVS ...

Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports Required Candidate profile Good relevant experiences for RA role in medical device and or pharmaceutical industry Good understanding for regulations and policies issued by India, US FDA and EU

We are looking for a highly skilled and experienced Risk Management Specialist to join our team at Uniqus Consultech, an IT Services & Consulting company. Roles and Responsibility Develop and implement comprehensive risk management strategies to mitigate potential risks. Conduct thorough risk assessments and analyze data to identify trends and patterns. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Design and maintain effective risk management frameworks and procedures. Provide expert guidance on risk management best practices to stakeholders. Monitor and report on risk management performance metrics. Job Requirements Strong understanding of risk ...

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

We are looking for a skilled professional to join our team as an Operations & Strategy Role in Hevo Data, located in [location to be specified]. The ideal candidate will have 2-5 years of experience and a strong background in operations and strategy. Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Analyze data to identify trends and areas for improvement. Collaborate with cross-functional teams to drive process improvements. Design and implement new processes and procedures to enhance efficiency. Monitor and report on key performance indicators to stakeholders. Identify and mitigate risks to ensure compliance with regulatory requirements....

We are looking for a highly skilled Legal-Drafting Expert with 2 to 7 years of experience to join our team at HouseEazy. The ideal candidate will have a strong background in drafting legal documents and providing expert advice on legal matters. Roles and Responsibility Draft, review, and negotiate legal documents such as contracts, agreements, and policies. Provide expert advice on legal matters to support business operations and decision-making. Conduct research and analysis to stay updated on changes in laws and regulations that may impact the company. Collaborate with cross-functional teams to ensure compliance with legal requirements. Develop and implement effective legal strategies to m...

Develop detailed project plans including scope, objectives, timelines, and resource requirements. Collaborate with engineering teams to ensure technical requirements are clearly defined and met. Required Candidate profile Lead and motivate cross-functional project teams, fostering a collaborative environment. Manage team performance, provide guidance, and support professional development.

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Sr Mgr Regulatory Affairs Date: Jul 18, 2025 Location: Bangalore, India, 560064 Company: Teva Pharmaceuticals Job Id: 62865 Who we are The opportunity Ensure pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise for internal and authority-related inquiries and problem-solving. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. S...

We are looking for a highly skilled and experienced Legal Counsel to join our team at Vakilsearch, responsible for providing legal expertise and guidance on transaction advisory and corporate legal matters. The ideal candidate will have 7-10 years of experience in the field. Roles and Responsibility Provide legal counsel on transaction advisory and corporate legal matters. Draft and review contracts, agreements, and other legal documents. Conduct legal research and analysis to support business decisions. Collaborate with cross-functional teams to ensure compliance with laws and regulations. Develop and implement legal strategies to mitigate risks and protect company interests. Stay updated w...