Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories Publishing and RIM Analyst in Hyderabad for global eCTD submission operations professionals.
The regulatory landscape in global pharmaceuticals is evolving rapidly, with increasing emphasis on digital submissions, structured data, and compliance-driven workflows. Dr. Reddy’s Laboratories is currently seeking qualified professionals for the position of Regulatory Affairs – Publishing & RIM Operations Analyst at its Hyderabad location.
This opportunity is ideal for candidates with expertise in eCTD publishing, Regulatory Information Management (RIM), IDMP standards, and document management systems who are looking to advance their careers in global regulatory operations. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
Company Overview
Dr. Reddy’s Laboratories is a leading Indian multinational pharmaceutical company with operations in over 60 countries. The organization focuses on research-driven innovation and affordable healthcare solutions across APIs, formulations, biosimilars, and specialty medicines.
Through its Integrated Product Development Organisation (IPDO), the company accelerates product development and regulatory approvals, ensuring timely access to medicines across regulated and emerging markets. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
Job Location & Employment Type
- Location: Hyderabad, Telangana
- Work Mode: On-site
- Employment Type: Full-Time
- Department: Integrated Product Development Organisation (IPDO)
- Industry: Pharmaceuticals / Regulatory Affairs
Open Position Details
Regulatory Affairs – Publishing & RIM Operations Analyst
This role supports global regulatory submissions and regulatory information systems. The selected candidate will work on dossier publishing, submission tracking, regulatory database management, and compliance initiatives aligned with international regulatory standards.
Key Roles & Responsibilities
1. eCTD Publishing & Global Submission Management
- Prepare, compile, and publish eCTD sequences for international regulatory submissions
- Conduct document quality control including metadata validation, hyperlinking, bookmarking, and structure verification
- Ensure compliance with ICH, EU, and other regional regulatory guidelines
- Manage gateway submissions to Health Authorities
- Track submission timelines and support regulatory calendars
- Maintain submission archives and lifecycle management records
2. Regulatory Information Management (RIM)
- Maintain and update regulatory databases and master product records
- Ensure data accuracy, governance, and SOP adherence
- Generate dashboards, KPI reports, and submission tracking metrics
- Support system upgrades and participate in User Acceptance Testing (UAT)
- Contribute to IDMP readiness initiatives in line with EU regulatory expectations
3. Document Management Systems (DMS – Veeva or Similar)
- Manage document lifecycle within DMS platforms
- Oversee version control and approval workflows
- Configure access controls, permissions, and regulatory workflows
- Provide documentation support during audits and inspections
- Ensure regulatory documentation compliance and traceability
4. Regulatory Expense & Compliance Tracking
- Monitor Health Authority fees and regulatory expenses
- Track vendor invoices and cost center allocations
- Maintain financial reports, accrual records, and monthly spend summaries
- Ensure compliance with financial approval workflows
Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
Eligibility Criteria
Educational Qualification
- Master’s Degree in Pharmacy
- Master’s Degree in Life Sciences
- Master’s Degree in Chemistry
- Or related scientific discipline
Experience
- Relevant experience in Regulatory Affairs Publishing, RIM operations, or DMS systems preferred
- Exposure to global regulatory environments (US, EU, or emerging markets) is advantageous
Required Skills & Technical Knowledge
- Strong understanding of eCTD lifecycle management
- Familiarity with global regulatory submission standards
- Knowledge of IDMP compliance frameworks
- Experience with Veeva or equivalent DMS platforms
- High attention to detail and regulatory compliance orientation
- Ability to manage strict submission timelines
Preferred Competencies
- Experience configuring and validating regulatory systems
- Analytical skills for preparing dashboards and regulatory reports
- Strong cross-functional collaboration skills
- Familiarity with APIs, formulations, and biologics regulatory pathways
Salary & Benefits
The official job notification does not disclose the salary package. Compensation will be offered as per company norms based on qualifications and experience. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
Employee benefits may include:
- Medical and life insurance coverage
- Maternity and paternity support policies
- Learning and development programs
- Relocation and joining assistance (where applicable)
- Inclusive workplace culture focused on ethical healthcare
Selection Process
The recruitment process may include:
- Online Application Submission
- Resume Screening
- Technical Interview(s)
- HR Discussion
- Final Offer
Shortlisted candidates will be contacted by the recruitment team for further steps. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
How to Apply
Interested candidates should apply through the official online application portal of Dr. Reddy’s Laboratories under the Regulatory Affairs – Publishing & RIM Operations Analyst job listing.
Applicants are advised to keep their updated resume ready and ensure accurate information while submitting their application. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
Important Dates
- No specific closing date has been mentioned. Early applications are recommended.
Why Apply for This Regulatory Affairs Role?
- Opportunity to work with a globally respected pharmaceutical organization
- Exposure to end-to-end global regulatory submissions
- Hands-on experience in eCTD publishing and RIM systems
- Involvement in IDMP compliance and international regulatory frameworks
- Career growth within a science-driven and innovation-focused company
- Participation in global product lifecycle management initiatives
This position offers strong career progression for regulatory professionals aiming to develop expertise in digital submissions and regulatory information management systems. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform. We are not affiliated with Dr. Reddy’s Laboratories or any organization mentioned above. Candidates are advised to verify job details and apply only through official company channels. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
Qualified candidates interested in building a long-term career in global regulatory operations are encouraged to apply promptly and take advantage of this opportunity. Regulatory Affairs Jobs In Hyderabad at Dr Reddy Laboratories
