Are you passionate about regulatory compliance and drug safety? Join our IOSO Regulatory Affairs – OCE team as an Associate Regulatory Professional I in Bangalore and play a key role in shaping future regulatory frameworks. If you have a strong background in pharmaceutical regulatory affairs, we invite you to apply for this life-changing career opportunity!
Job Description
Key Responsibilities:
- Compile, submit, and manage Country-Specific Submission files (NDA, LCM, and post-approval changes) for assigned regions.
- Support affiliates in updating local regulatory requirements based on agency guidelines and distributor inputs.
- Manage relationships with key stakeholders to ensure smooth regulatory processes.
- Ensure compliance with global and regional regulatory requirements.
- Interact with regulatory agencies to expedite approvals and address queries.
- Provide regulatory guidance throughout the product lifecycle, including impact assessments for production and labeling changes.
Qualifications & Skills:
- Education: Master’s degree in Science, Pharmacy, Medicine, or a related field.
- Experience: Minimum 2+ years in Regulatory Affairs or a related function in the pharmaceutical industry.
- Regulatory Expertise:
- Intermediate knowledge of pharmaceutical regulatory frameworks.
- Familiarity with global/regional regulatory guidelines (e.g., FDA, EMA, CDSCO).
- Understanding of Regulatory IT systems (e.g., Veeva, DMS, eCTD submissions).
- Soft Skills: Strong communication, stakeholder management, and strategic thinking.
About the Department
The IOSO Regulatory Affairs – OCE team ensures regulatory compliance for new drugs, devices, and digital health products. We handle:
- Clinical trial applications
- New drug approvals
- Post-approval changes & lifecycle management
- Expanding product availability in global markets
Based in Bangalore, our team fosters a collaborative, fast-paced environment where professionals can drive real impact in healthcare.
How to Apply
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