This job offer is not available in your country.
Mgr Regulatory Affairs
Teva Pharmaceuticalsbangalore, India1 day ago
Job descriptionManage all submissions and maintenance activities related to Branded / Specialty and Generic products in APAC region. Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites / suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity. Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc) Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams.. Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system. Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements. Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them. Work closely with market RA in APAC region to complete all assigned activities B. Pharm / M. Pharm (preferred) with 10+ years of experience Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices. Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)
The opportunity
- Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.
- Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.
- Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.
How you’ll spend your day
Regulatory Submissions
Regulatory Intelligence / Expertise / Guidance / Education
Your experience and qualifications
Create a job alert for this search
Regulatory • bangalore, India
Related jobs
)
- 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
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
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: 2 days ago
- Promoted
- New!
Regional Sales Manager
AwignGreater Bengaluru Area, India Awign is a "work-as-a-service" platform that empowers enterprises to execute diverse work requirements through a network of 1.
We cater to a wide range of enterprise needs, including promoter deploy...Show moreLast updated: 2 hours 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
- Promoted
Oracle R12 EBS SCM ASCP Consultant
Hexaware TechnologiesBangalore Rural, Karnataka, India Position Title : Oracle R12 EBS SCM ASCP Consultant.Location : Any Hexaware Locations.This position involves leading the implementation, configuration, and support of Oracle R12 SCM modules, Inventor...Show moreLast updated: 17 days ago
- Promoted
MEP Project Manager
Exide Energy Solutions LtdDevanahalli, Karnataka, India Exide Energy Solutions Limited (EESL) is one of the fastest growing companies who has vision to solve social issues regarding energy, environment, resource, etc with producing lithium-ion battery p...Show moreLast updated: 9 days ago
- Promoted
RMS Technical Expert - OSAT
Tata ElectronicsKolar, Karnataka, India The RMS Technical Expert will be responsible for the design, deployment, and optimization of Reliability Monitoring Systems in an OSAT (Outsourced Semiconductor Assembly & Test) manufacturing envir...Show moreLast updated: 9 days ago
- Promoted
Project Manger - Pharma
RED Globalhosur, tamil nadu, in Project Manger - Pharma - Remote - 12 month contract, extendable.The Project Manager will lead the delivery of SAP S / 4HANA initiatives within a pharmaceutical environment, ensuring alignment with b...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 BiologicsBangalore, Bangalore (division), 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: 12 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
HR Compliance
Tata ElectronicsKolar, Karnataka, India Tata Electronics Private Limited (TEPL) is a greenfield venture of the Tata Group with expertise in manufacturing precision components.
Tata Electronics (a wholly owned subsidiary of Tata Sons Pvt.I...Show moreLast updated: 26 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
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
- Promoted
Security Technology Lifecycle Analyst
HR PLACEMENT CONSULTANTS (HRPC)Bangalore Rural, Karnataka, India Position - Analyst - Security Technology Lifecycle Analyst.Job Type - Full-time (Third party payroll •).The Security Technology Lifecycle Analyst plays a critical role in supporting the Corporate Se...Show moreLast updated: 22 days ago
- Promoted
R&D Assistant Manager / Deputy Manager for a leading Food manufactring co at Hosur.
The Banyan HR Consults ChennaiHosur, Tamil Nadu, India Designation : R&D Assistant Manager / Deputy Manager for a leading Food manufacturing co at Hosur.Qualification : Graduate / Postgraduate in Food Technology / MSc Food Technology from Agri University.Expe...Show moreLast updated: 9 days 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
AI Leader
Tata ElectronicsKolar, Karnataka, India Tata Electronics Private Limited.TEPL) is a greenfield venture of the.India’s first AI-enabled state-of-the-art Semiconductor Foundry.
This facility will produce chips for applications such as power...Show moreLast updated: 9 days ago
- Promoted
- New!
Senior Technical Manager of Artificial Intelligence
Ecolab Digital CenterGreater Bengaluru Area, India This role combines technical excellence with leadership, project management & technical ownership.This role demands deep technical expertise across cloud infrastructure, APIs, data engineering and ...Show moreLast updated: 2 hours ago