Regulatory Affairs Jobs at Dr. Reddy’s Careers | Apply Now for Pharma Jobs in Hyderabad
Looking for Regulatory Affairs Jobs with a global pharmaceutical leader? Dr. Reddy’s Careers offers an excellent opportunity for Regulatory Affairs professionals in Hyderabad to work on publishing and RIM operations across global regulatory regions. These Regulatory Affairs Jobs at Dr. Reddy’s Careers provide hands-on exposure to eCTD publishing, RIM systems, IDMP readiness, and document management systems within a leading multinational pharmaceutical organization.
- Job Title: Regulatory Affairs – Publishing & RIM Operations Analyst
- Location: Hyderabad, Telangana, India
About the Company
Dr. Reddy’s Laboratories Ltd. is a leading Indian multinational pharmaceutical company headquartered in Hyderabad, Telangana, founded in 1984 by Dr. K. Anji Reddy. The company develops, manufactures, and markets a wide range of generic medicines, branded formulations, active pharmaceutical ingredients (APIs), biosimilars, and OTC products across key therapy areas, including oncology, cardiovascular, gastroenterology, diabetology, and dermatology. With a strong global footprint across regulated and emerging markets, Dr. Reddy’s serves millions of patients worldwide and is driven by its purpose, “Good Health Can’t Wait,” focusing on affordable, accessible, and innovative healthcare solutions.
Job Description
A person should have a good experience in handling the publishing activities, handling the RIMS, IDMP & DMS.
eCTD Publishing & Submissions
- Assemble, publish, and validate eCTD sequences across global regions.
- Perform document QC (metadata, bookmarks, hyperlinks, compliance).
- Apply regional guidelines (ICH, EU, etc.) and resolve validation errors.
- Manage HA gateway submissions, acknowledgments, and sequence tracking.
- Maintain the submission calendar and support regulatory timelines.
Regulatory Information Management (RIM)
- Maintain RIM master data (products, registrations, HA interactions).
- Ensure data quality, governance, and adherence to SOPs.
- Support workflow management, system updates, and UAT activities.
- Generate dashboards, reports, and KPIs for regulatory teams.
- IDMP readiness to meet the EU agencies’ expectations.
Document Management System (DMS – Veeva, etc.)
- Manage document lifecycles and ensure metadata/versions are accurate.
- Support configuration of workflows, roles, and permissions.
- Provide user support, training, and ensure audit-readiness.
Expense Management
- Track and reconcile regulatory expenses (HA fees, vendor invoices).
- Maintain cost-center rules, categories, and approval flows.
- Provide monthly spend reports, accrual inputs, and compliance checks.
Key Responsibilities
- Assemble, publish, and validate eCTD sequences across global regions.
- Perform document QC and resolve validation errors.
- Maintain RIM master data and ensure data governance.
- Manage DMS lifecycles and ensure audit readiness.
- Track regulatory expenses and provide compliance reports.
Qualifications
- Master’s in Life Sciences, Pharmacy, Chemistry, or related field.
