3208 Regulatory Affairs Jobs - Page 2

Qualification :MSc in Chemistry, Organic Chemistry, Molecular Chemistry 5 to 7 years in API Manufacturing (Active Pharmaceutical Ingredients) Job Role :- Assist in development, implementation, and maintenance o

Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry for filing of products in various regulatory agencies Knowledge: Strong understanding of regulatory guidelines and

•Deep understanding of Indian Automotive regulations CMVR, BIS, AIS •Participation in Technical Regulatory committees within SIAM and external agencies on upcoming Safety Regulations discussions •Familiarity with regulatory bodies and committees .

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission tim...

We are seeking a diligent Regulatory Affairs specialist to support our compliance efforts, ensuring adherence to FSSAI, Legal Metrology, and AYUSH regulations. The successful candidate will play a key role in preparing and submitting statements for new product endorsements, license renewals, and quarterly/annual returns, maintaining strict regulatory compliance. Key Responsibilities: FSSAI Compliance: Review formulations and packaging to ensure alignment with FSSAI guidelines, manage product endorsements via the FOSCOS Portal, and provide recommendations for necessary modifications to meet compliance requirements. Artwork & Labeling Compliance: Validate and coordinate changes in product form...

As an experienced candidate with 8-12 years of experience, you will be responsible for the following key roles and responsibilities: - Familiarity with Pharmacovigilance Risk Management Plan (RMP) processes - Proficiency in Pharmacovigilance Periodic Safety Reports (PSR) processes - Ability to translate business requirements into technical specifications - Previous experience working with Top-30 Pharma companies - Cross-functional experience in safety, pharmacovigilance, and regulatory affairs - Good to have experience with Veeva.RIM - Good to have experience with Feith Orbit platform - Strong organizational skills and excellent verbal and written communication abilities If you are intereste...

As a part of Jubilant Pharma Limited, you will be contributing to a global integrated pharmaceutical company that offers a wide range of products and services to customers across various geographies. The company organizes its business into two segments: Specialty Pharmaceuticals and Generics & APIs. **Role Overview:** Joining Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, you will be a part of a team that contributes to the company's Research & Development and manufacturing units. JGL has Research & Development units in Noida and Mysore, along with manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand. **Key Responsibilities:** - Engage in the develo...

Company Name Givaudan Job Title Senior Regulatory Specialist Job Location: Mumbai Maharashtra Description Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with. Every day, your talent, your innovative spirit, and your determination will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human b...

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 & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorke...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a Trusted Emerging Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top managem...

What you will do The Associate Director is a senior people leader responsible for the operational effectiveness, staff engagement, and strategic alignment of Amgens CMC & Device Regulatory Team in Amgen India (AIN). This role provides leadership across multiple functional interfaces and global sites, ensuring that AIN staff are supported, connected, and empowered to deliver high-quality regulatory and operational work that advances Amgens mission to serve patients. The Associate Director will lead a diverse team accountable for regulatory and operational deliverablesincluding change assessment, regulatory strategy across phases of development and modalities (including medical devices), and g...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations Associate Qualifications: BCom Years of Experience: 1 to 3 years Language - Ability: English(Domestic) - Intermediate 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, medic...

About The Role Project Role : Application Support Engineer Project Role Description : Act as software detectives, provide a dynamic service identifying and solving issues within multiple components of critical business systems. Must have skills : Asset Management Good to have skills : Asset Life Cycle ManagementMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Support Engineer, you will act as software detectives, providing a dynamic service identifying and solving issues within multiple components of critical business systems. Your day will involve troubleshooting, analyzing, and resolving software-related issues ...

The Regulatory Executive (Personal Care) will ensure compliance of cosmetic and personal care products with all applicable laws and regulations, including the Drugs and Cosmetics Act, 1940 , Drugs and Cosmetics Rules, 1945 , and related FDA requirements. The role involves managing product registrations, approvals, and documentation while supporting cross-functional teams in launching compliant products in the Indian and international markets. Reports to: Lead Manager Regulatory & Compliance Responsibilities:- Regulatory Compliance Ensure all cosmetic and personal care products comply with the Drugs & Cosmetics Act and Rules , including Schedule S, Q, and related labelling requirements. Prepa...

Perform US Export/Reexport and APJ local country export control review and determine license/regulatory requirements for all sales transactions. (30%) Analyze partner reviews relating to potential matches when screening customers and end users. (20%) Perform ECCN validation of new articles created in SAP. (15%) Perform risk assessments on end-customers and categorize them according to a pre-determined criterion. (15%) Assist in determining the in-country HS codes for articles created in ERP systems. (10%) Support reporting from ERP system for proactive export license analysis. Analyze metrics & determine actions further to improve turnaround time or reduce export holds. (5%) Prepare other tr...

Assist in managing GST advisory projects and enterprise compliance processes. Conduct research and ensure updates on the latest changes in GST laws and regulations . Communicate with clients and internal teams to provide support on GST compliance matters. Contribute to the implementation of GST compliance strategies for various enterprises. Prepare and maintain documentation for GST audits , filings, and advisory reports

Process and monitor daily settlements across all partner banks and payment channels. Ensure timely transaction confirmation, matching, and settlement. Investigate and resolve settlement discrepancies in coordination with banks, acquirers, and internal stakeholders. Coordinate with business, compliance, and custodial teams to ensure smooth and accurate settlements. Perform daily reconciliations between internal systems and acquiring partners. Monitor failed transactions and take corrective measures to minimize financial exposure and operational risk. Maintain accurate records of settlement and transaction activities for audit and compliance purposes. Support continuous process improvement, au...

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Accept All Cookies Find a Career With Purpose at Teva Search by Postal Code...

Following GMP and GDP and data integrity Responsible for DP manufacturing facility manufacturing activities (operation and cleaning of autoclaves, compounding vessels, filtration vessels, pass-boxes, filter integrity machines, leak testing machine, glove integrity tester, LAFs, bag sealing machine, weighing balances, O RABS, washing & tunnel with filling lines and packaging) for DP. Responsible for operation and cleaning of Automatic visual inspection machine and labelling machine for DP. Preparation, review and execution of Study protocol/SOPs/QRM/ Study report/QRM report in the drug product facility. Assist the validations/study and routine validations/study of equipment and facility. Iden...

Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team i...

Assist with Asia Compliance Policies and Compliance Communication/ Alerts related tracking, ongoing reviews, and rollouts, and coordinate with regional owners / stakeholders on the same Assist the GCD team in checking relevant regulatory websites for Monthly regulatory and sanctions database (FINRA, SEC, UK FSA etc.) for press releases or monthly bulletins Support the GCD team in maintaining the latest information with regards to regulatory inspections, examinations , and any other communications including selfreporting of breach cases to applicable authorities, and providing information on corresponding remedial actions taken within Nomura Group entities globally Support the GCD team on sta...

Test, validate, and continuously refine advanced control testing frameworks and methodologies, incorporating innovative techniques to address complex or emerging risks Conduct and oversee comprehensive, high-risk assurance reviews, ensuring that test plans, workpapers, and outcome reports meet the highest quality standards Lead the development, implementation, and optimization of new controls, collaborating with executive stakeholders to ensure alignment with the organization s strategic objectives Evaluate cyber risk and non cyber risk controls at an enterprise scale, identifying systemic issues, influencing remediation strategies, and driving continuous improvements that reduce risk exposu...

Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added regulatory affairs service and deliverables for existing products, new product introductions and product changes across the ISC. supporting SAP Regulatory controls to ensure products are safe, effective, and meeting the target market Regulatory requirements. You are responsible for Supporting RA Team for the Indian Sub Continent to ensure on time registrations,...

About The Role : Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Se...

About The Role : Job titleBond Analytics Analyst LocationMumbai, India Corporate title Associate Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS) With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency...