Teva Pharmaceuticals, a global leader in generic medicines, is hiring for two exciting Regulatory Affairs Associate roles in India. With a mission to make healthcare affordable and accessible, Teva impacts 200 million lives daily through its products, many listed on the WHO’s Essential Medicines List. These opportunities in Bangalore (Job ID: 62840) and Navi Mumbai (Job ID: 63515) offer a chance to contribute to innovative regulatory processes in a dynamic, inclusive workplace. Whether you’re passionate about pharmaceutical labeling or post-approval submissions, Teva provides a platform to grow your career in regulatory affairs.
Job Responsibilities
Regulatory Affairs Associate I (Bangalore, India)
- Editorial Tasks: Review SmPC, PIL, and packaging materials using a review protocol, adapt texts to QRD templates, proofread, and manage product information in the GRIDS database.
- Translation Management: Plan and coordinate translations of English product information into EU languages for Centralized Procedures (CPs), including Norway and Iceland. Conduct internal QC checks and manage linguistic reviews.
- Regulatory Monitoring: Screen for innovations in the EU regulatory environment, focusing on central approvals, and monitor guidelines and best practices.
- Administrative Duties: Act as Cost Center Administrator in SAP, manage purchase requisitions in ARIBA, and handle inquiries from departments and service providers.
- Team Collaboration: Work in a team environment and perform additional duties as required by management.
Regulatory Affairs Associate III (Navi Mumbai, India)
- Submission Management: Prepare, compile, and submit high-quality post-approval submissions to Health Canada, ensuring compliance with regulations and corporate standards.
- Regulatory Strategy: Develop and implement regulatory strategies for assigned projects, collaborating with R&D and other business functions to meet timelines.
- Change Control Evaluation: Assess change controls for regulatory filings per Health Canada guidelines and manage timely post-approval activities.
- Regulatory Compliance: Stay updated with Teva procedures, Health Canada, and ICH regulations.
- Business Development: Support assessments and other assigned projects as needed.
Qualifications and Skills
Regulatory Affairs Associate I (Bangalore)
- Experience: Experience in regulatory affairs or basic knowledge of European pharmaceutical law.
- Education: Completed training as a pharmaceutical-technical assistant or medical assistant.
- Skills: Intermediate to advanced English (spoken and written), excellent MS Office skills, basic knowledge of European regulatory affairs, and project management experience.
Regulatory Affairs Associate III (Navi Mumbai)
- Experience: 5-7 years in regulatory affairs (post-approval, EU/FDA, preferably Health Canada) and 7-10 years in pharmaceuticals, with preference for sterile products experience.
- Education: M. Pharma degree in a scientific discipline.
- Skills: Excellent communication, organizational skills, attention to detail, and strong critical thinking.
Benefits of Working at Teva Pharmaceuticals
- Global Impact: Contribute to Teva’s mission of improving global health, impacting 200 million people daily.
- Inclusive Workplace: Teva fosters a diverse, equal-opportunity environment across 60 countries.
- Career Growth: Engage in innovative regulatory projects with opportunities for professional development.
- Team Collaboration: Work with a diverse team of professionals in a supportive, dynamic setting.
How to Apply
Application Link Regulatory Affairs Associate I (Job ID: 62840, Bangalore)
Application Link Regulatory Affairs Associate III (Job ID: 63515, Navi Mumbai)
