3208 Regulatory Affairs Jobs - Page 25

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Sel...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation/Post Graduate Diploma in Finance/Bachelors degree with Finance specialization Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding an...

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, bud...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving cus...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving cus...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving cus...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Sel...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving cus...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? About The Role :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of produc...

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CERs that support the applicable regulatory submission requirements for the medical device products. An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 4-5 years of CER writing experience is essential. A minimum of 4-5 years of medical writing/reviewing experience is needed. The experience is expected to be curren...

Role & responsibilities Job Description: Responsible for leading and managing all regulatory activities for the Indian domestic market to ensure timely product approvals, license renewals, and compliance with CDSCO and State FDA regulations. Key Responsibilities: Oversee submission, approval, and renewal of product licenses, manufacturing, and marketing authorizations. Ensure compliance with Drugs & Cosmetics Act, Schedule M, and other applicable regulations. Liaise with CDSCO, State FDA, and other regulatory authorities for product-related matters. Review and approve dossiers, product artworks, and labelling as per regulatory norms. Monitor changes in drug regulations and implement necessar...

Job Title: Regulatory Affairs Executive Department: Regulatory Affairs Location: Hyderabad Experience: 1-5 Years Industry: Pharmaceuticals (Injectables / OSD) About Jodas Expoim Jodas Expoim is a fast-growing, global pharmaceutical company committed to delivering high-quality, affordable medicines. We focus on complex injectables and are driven by innovation, compliance, and excellence. Key Responsibilities: Prepare, compile, and review registration dossiers (CTD/eCTD formats) for product submissions to ROW/ CIS markets in compliance with local regulatory requirements. Coordinate with cross-functional teams (Formulation, QA, QC, Production, and RA teams) to gather and verify technical docume...

Design & oversee biosimilar clinical trials with CROs, ensuring regulatory compliance. Coordinate with medical advisors, manage IP logistics, submissions, and pharmacovigilance, and serve as main contact for government grant projects and reports.

About Zscaler Serving thousands of enterprise customers around the world including 45% of Fortune 500 companies, Zscaler (NASDAQ: ZS) was founded in 2007 with a mission to make the cloud a safe place to do business and a more enjoyable experience for enterprise users. As the operator of the world’s largest security cloud, Zscaler accelerates digital transformation so enterprises can be more agile, efficient, resilient, and secure. The pioneering, AI-powered Zscaler Zero Trust Exchange™ platform, which is found in our SASE and SSE offerings, protects thousands of enterprise customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Named...

Sakar Healthcare Ltd incorporated in 2004 has emerged as a leading pharmaceutical manufacturer based in Western India, specialized with innovative oncology solutions. With the research-driven API-integrated EU GMP approved oncology orals & injection formulation manufacturing units, Sakar is ready to cater the global markets with diverse product range and business models. Mentor regulatory team of 12, conduct training sessions on the latest regulatory updates have experience of trouble shooting with good communication skills client handling. Preparing/ checking and submitting technical files and compilation of dossiers in CTD format of Product life-cycle management in ROW & EU markets. Ensuri...

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics and APIs, comprising Solid Dosage Formulations and Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research and Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another a...

Hi, We are hiring for Head -Quality & Regulatory | Bangalore Location. Job purpose Implement, maintain and further develop the ZEISS India Management System, aligned with the Corporate ZEISS Management System, maintain the ISO 9001 certification requirements, and the business requirements across the pan-India ZEISS organization. Regulate, control and improve the quality of all processes throughout the business and the final product to meet the quality needs of our customers and other stakeholders. Embed a culture of continuous improvement throughout the company. Lead the team to achieve quality management system targets for customers and business goals. Main Accountabilities Quality Manageme...

Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control,...

This role purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, products, and services We are looking for an experienced individual in Global Drug Development Regulatory Affairs to lead technical activities for the solutions that re-define how Novartis operates, You will be working on strategic initiatives with the mandate to deliver solutions, which will bring transformative change to the business domain and will allow Novartis to realize a competitive advantage, About The Role Position Title Assoc Dir DDIT DEV RA Sol Arch, Location Hyd-India Hybrid About The Role This role purpose is to act as a consultant and advisor providing guida...

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats. Responsible for final review of dossier before submission. Reviewing artwork for products as per relevant regulatory authority requirements. Coordination with F&D, QA, QC & Store for documentation In-depth knowledge of pharmaceutical documentation & regulatory guidelines. To coordinate with technical team for documents required for dossier. Country Experience Preferred: CIS, LATAM Dosage Form Experience: Soild Oral + Injectable Preferred candidate profile

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Description Regulatory Manager (CMC, EU Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

As the Manager Regulatory Affairs at Kenvue, you will lead a team responsible for developing regulatory strategies across India, providing guidance on local requirements to product development teams. Your responsibilities will include managing regulatory deliverables for various products within your geographical and brand area, ensuring consistency in regulatory positions, and maintaining current products throughout their lifecycle. You will also represent the Regulatory Affairs function within the Franchise. Key Responsibilities: - Provide regulatory input and guidance to product development teams - Support business initiatives by influencing and approving the product portfolio - Conduct ri...

You will be joining the Formulation R&D team at Hetero Drugs as a Scientist II, focusing on the development of sterile injectable formulations, including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. Your role will be crucial in advancing product development for regulated markets such as the US, Europe, and ROW. You will be responsible for comprehensive formulation design, process optimization, regulatory documentation, and coordination across departments. - Independently lead the development of sterile injectable products, including aqueous, non-aqueous, lyophilized, and peptide-based formulations. - Conduct formulation studies, process optimization, and scale-up a...