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Dr. Reddy’s Laboratories, a globally recognized pharmaceutical leader, is inviting applications for the role of Regulatory Affairs – Publishing & RIM Operations Analyst at its Hyderabad location. This opportunity is ideal for professionals with expertise in eCTD publishing, Regulatory Information Management (RIM), IDMP compliance, and document management systems who want to build a long-term career in global regulatory operations.
With a presence across 60+ countries and a strong innovation-driven pipeline, Dr. Reddy’s continues to expand its Integrated Product Development Organisation to accelerate access to affordable medicines worldwide.
Job Overview
- Role: Regulatory Affairs – Publishing & RIM Operations Analyst
- Location: Hyderabad, Telangana (On-site)
- Job Type: Full-Time
- Department: Integrated Product Development Organisation
- Industry: Pharmaceuticals / Regulatory Affairs
- Experience Level: Relevant experience in Regulatory Publishing & RIM preferred
- Qualification: Master’s in Life Sciences, Pharmacy, Chemistry, or related field
Key Responsibilities
eCTD Publishing & Global Submissions
- Assemble, publish, and validate eCTD sequences for global regulatory submissions.
- Perform document quality checks including metadata validation, hyperlinks, bookmarks, and compliance review.
- Apply regional regulatory requirements such as ICH and EU guidelines.
- Manage Health Authority gateway submissions and maintain submission tracking timelines.
- Support regulatory calendars and ensure timely dossier delivery.
Regulatory Information Management (RIM)
- Maintain and update RIM master data, including product registrations and HA interactions.
- Ensure strong data governance, accuracy, and SOP compliance.
- Generate dashboards, reports, and KPIs for regulatory teams.
- Participate in system upgrades, workflow optimization, and UAT activities.
- Support IDMP readiness aligned with EU regulatory expectations.
Document Management Systems (DMS – Veeva, etc.)
- Manage document lifecycle and version control within DMS platforms.
- Configure workflows, permissions, and user roles.
- Provide training and ensure audit readiness for regulatory documentation.
Regulatory Expense Management
- Track Health Authority fees and vendor invoices.
- Maintain cost-center compliance and approval workflows.
- Provide monthly financial tracking, accrual data, and spend reports.
Required Qualifications
- Master’s degree in Pharmacy, Life Sciences, Chemistry, or related discipline.
- Experience in Regulatory Affairs Publishing, RIM systems, or DMS platforms preferred.
- Working knowledge of:
- eCTD lifecycle management
- Global regulatory submission standards
- IDMP compliance frameworks
- Veeva or equivalent DMS tools
- Strong attention to detail, compliance mindset, and ability to manage regulatory timelines.
Preferred Skills
- Familiarity with global markets such as US, EU, and emerging markets.
- Experience in regulatory systems configuration and validation.
- Analytical skills for regulatory dashboards and reporting.
- Cross-functional collaboration within clinical, quality, and regulatory teams.
Why Join Dr. Reddy’s Laboratories?
- Work with a science-driven global pharmaceutical company serving 1.5+ billion patients.
- Exposure to end-to-end product lifecycle across APIs, formulations, and biologics.
- Career development through structured learning and global regulatory exposure.
- Competitive benefits including:
- Medical & life insurance coverage
- Family-friendly policies (maternity & paternity benefits)
- Learning and development programs
- Relocation and joining support
- Inclusive workplace promoting innovation, diversity, and ethical healthcare delivery.
How to Apply
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