This job offer is not available in your country.
Regulatory Affairs Associate III
Teva Pharmaceuticalsbangalore, India21 hours ago
Job descriptionLabeling Responsible for creating and updating compliant English product information for EU procedures. Providing instructions and guidance to local RA (e.g. calculations due to new excipients warnings). Discussion of the content of product information for innovative products (pre- and post-approval) in project teams. Evaluate and approve change requests; coordinate submissions with EU regulatory units. Collaborate on patent-related issues with Global IP Group. Contribute to readability studies and ensure PIL readability and compliance with legal requirements. Adaption to reference medicinal product (generic, hybrid, biosimilar procedures). Preparation of Expert statements (justification) for type II variations. Providing scope of variation to regulatory affairs. Performing plausibility check and providing wording to be in line with QRD requirements and Standard Terms for module 3 updates. Monitoring Monthly monitoring and communicating safety updates from EU authority websites. Track reference product updates and legal / guidance changes affecting product information. Pharmacovigilance Assess need for updates based on Company Core Safety Information (CCSI). Implement PV triggered and non-PV triggered safety updates (e. g. PRAC / PSUSA / PSUFU, Referrals (Articles 31 + 107i), article 30 procedures, etc.) in line with SOPs; collaborate on safety-related actions with Pharmacovigilance and QA. Participation in Product Safety Group (PSG) Meetings. Implementation of internal signals (including determining PIL wording). Scientific Work & Authority Communication Respond to authority deficiency letters in collaboration with other departments. Mockups Coordinate creation and approval of packaging mockups, Braille, and specimens. Address authority queries and ensure compliance with EU regulations. Experience : 5 to 6 years in relevant fields, (medicinal information and EU labeling in the pharmaceutical industry) ideally in Regulatory Affairs. Education : Completed at least 8-semester university degree in natural sciences (e.g., Pharmacy (preferred), Biology, Human Biology, Medicine, Food Chemistry) Other : Advanced English (spoken and written), strong MS Office skills, knowledge of European Pharmaceutical Law and Regulatory Affairs.
The opportunity
- Ensure the 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 to address internal and authority-related inquiries and resolve labeling issues.
- Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling.
How you’ll spend your day
Your experience and qualifications
Create a job alert for this search
Associate Regulatory • bangalore, India
Related jobs
Years of relevant experience in regulatory.Independently use judgement, strict adherence to GSK and IRM plan quality and process expectations, industry and regulatory standards and drug development...Show moreLast updated: 30+ days ago Author and compile Regional / Country PI as per regulatory authority labelling requirements and GSK process and standards.
Author and compile market-specific supporting documentation for labelling sub...Show moreLast updated: 30+ days ago 
Responsible for chemistry, manufacturing and controls of regulatory matters relating to registrations and / or maintenance of business activities.
Prepare sections of registration files, briefing book...Show moreLast updated: 30+ days ago 
Coordination of CTA submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with Organization policy and pro...Show moreLast updated: 30+ days ago 
- Promoted
Regulatory Compliance Specialist -2+
Jupiter AI Labshosur, tamil nadu, in Regulatory & Compliance Specialist.India and international destination countries.This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related ...Show moreLast updated: 1 day ago
- Promoted
Associate Dean - Academics
Dayananda Sagar UniversityKanakapura, Karnataka, India Job Title : Associate Dean - Academics.Dayananda Sagar University (DSU), a premier institution in Bengaluru known for its excellence in.
Professor & Associate Dean - Academics.We are seeking a vision...Show moreLast updated: 9 days ago
- Promoted
Regulatory Affairs Excellence Specialist
PhilipsBengaluru, Karnataka, India Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organiza...Show moreLast updated: 1 day ago
- Promoted
Associate Manager II - Taxation
NaviBengaluru, Karnataka, India Associate Manager II - Taxation.The Taxation team at Navi is responsible for managing all aspects of the company’s tax obligations, ensuring compliance.
The team works on tax planning, reporting, an...Show moreLast updated: 8 days ago
- Promoted
Associate Manager II - Legal (General Corporate and Commercial Contracts)
NaviBengaluru, India The LSC team at Navi serves as a strategic partner to the business, ensuring the company's operations align with legal and regulatory frameworks.
The team provides comprehensive legal counsel across...Show moreLast updated: 30+ days ago
- Promoted
Manager Global Regulatory Affairs
Biocon BiologicsBengaluru, Karnataka, India Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Developme...Show moreLast updated: 6 days ago
- Promoted
Regulatory Affairs Specialist
Biocon BiologicsBengaluru, Karnataka, India Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.Developme...Show moreLast updated: 30+ days ago
- Promoted
Associate Manager - EHS
LifeStyles HealthcareBangalore Rural, Karnataka, India We are looking at Candidates who has exposure to the following : .EHS compliance , hands on experience in handling ETP, PCB with 8 to 10 years work experience.
Senior Manager – Human Resources.Englis...Show moreLast updated: 30+ days ago
- Promoted
Regulatory Affairs (Veeva-Vault RIM)
vueverse.Bengaluru, Karnataka, India We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets.Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Var...Show moreLast updated: 19 days ago
- Promoted
Associate Site Report Specialist
IQVIA IndiaHosur, Tamil Nadu, India Project role : Associate Site Report Specialist Work experiences : 4 to 6 years.Work location : Homebased Must have skills : CRA, Clinical Research Associate, Onsite Monitoring Job overview : Revi...Show moreLast updated: 30+ days ago
- Promoted
Unit-Level Traceability Technical Expert – OSAT
Tata ElectronicsKolar, Karnataka, India Tata Electronics (a wholly owned subsidiary of Tata Sons Pvt.India’s first AI-enabled state-of-the-art Semiconductor Foundry.
This facility will produce chips for applications such as power manageme...Show moreLast updated: 9 days ago
Senior Associate - Regulatory Project and Resource Management
ScaleneWorksBengaluru, Karnataka, IndiaQuick Apply
Regulatory Specialist III, Country Labelling
ScaleneWorksBengaluru, karnataka, IndiaQuick Apply
- Promoted
▷ (Apply Now) Regulatory Affairs Executive
Halma plcBengaluru, Karnataka, India About Halma : Halma is a global group of life-saving technology companies, driven by a clear purpose.We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including...Show moreLast updated: 30+ days ago
- Promoted
Senior Regulatory Manager
Biocon BiologicsBengaluru, Karnataka, India We are looking for a Regulatory Affairs professional with hands-on experience in biologics / biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions.The candi...Show moreLast updated: 22 days ago
Reg Associate Manager II - LM CD CMC Renewals
ScaleneWorksBengaluru, Karnataka, IndiaQuick Apply
- Promoted
Regulatory Affairs Executive
Halma plcBengaluru, Karnataka, India Halma is a global group of life-saving technology companies, driven by a clear purpose.We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs...Show moreLast updated: 30+ days ago
- Promoted
Audit Associate II
Elliott DavisBengaluru, Karnataka, India Our Mission, Vision, and Values.To provide exceptional service for our people, our customers, and our communities.To elevate all experiences by caring more.
Do the right thing, Service to others, Mu...Show moreLast updated: 30+ days ago
CTA / IND Regulatory Specialist
ScaleneWorksBengaluru, Karnataka, IndiaQuick Apply
- Promoted
Document Controller
Krishna Global Services Pvt. Ltd.Bangalore Rural, Karnataka, India Support and assist regional project management teams to manage and control their documentation of customers and vendors, including proposals, product-related issues, and drawings / documents in a tim...Show moreLast updated: 1 day ago