Looking to advance your career in Regulatory Affairs and Regulatory Operations? Abbott is hiring an Associate – CSCC & Registration Management (RM) for its Established Pharmaceuticals Division (EPD) in Mumbai (BKC). This opportunity is ideal for professionals with 2–5 years of experience in Regulatory Information Management (RIM), regulatory submissions, lifecycle management, and compliance activities.
If you have a science background and experience supporting regulatory operations, global submissions, and cross-functional collaboration, this role offers an excellent opportunity to work with one of the world’s leading healthcare companies.
Job Details
- Company: Abbott
- Job Title: Associate – CSCC & Registration Management (RM)
- Department: Regulatory Operations
- Division: Established Pharmaceuticals (EPD)
- Location: Mumbai, Maharashtra, India
- Employment Type: Full-Time
- Experience Required: 2–5 Years
- Education: Science Background
- Work Mode: On-site
- Shift: Standard
Key Responsibilities
As an Associate – CSCC & RM, you will:
- Support and administer Regulatory Information Management (RIM) systems.
- Maintain accurate and compliant regulatory data.
- Track global regulatory submissions, approvals, commitments, and product lifecycle activities.
- Collaborate with Regulatory Affairs, Pharmacovigilance, affiliates, and cross-functional teams.
- Support RIM system upgrades, validation, testing, and User Acceptance Testing (UAT).
- Troubleshoot regulatory data and system issues.
- Maintain regulatory data standards and governance processes.
- Support audit and inspection readiness activities.
- Assist in safety variation submissions and lifecycle management.
- Submit regulatory information to health authorities, including EMA XEVMPD.
- Coordinate Certificates, Module 1 documents, and legalization activities with affiliates.
- Maintain tracking logs and ensure timely completion of regulatory requests.
- Prepare monthly KPIs and compliance reports.
- Participate in continuous process improvement initiatives.
Eligibility Criteria
Candidates should have:
- Science background (B.Pharm, M.Pharm, M.Sc, Biotechnology, Life Sciences or equivalent).
- 2–5 years of Regulatory Operations or Regulatory Affairs experience.
- Knowledge of Regulatory Information Management (RIM) systems.
- Experience with regulatory submissions and lifecycle management.
- Understanding of regulatory compliance and documentation.
- Good analytical, communication, and stakeholder management skills.
- Exposure to UAT, validation, and regulatory databases is preferred.
Preferred Skills
- Regulatory Information Management (RIM)
- Regulatory Affairs
- Registration Management
- Regulatory Operations
- Product Lifecycle Management
- UAT & System Validation
- Regulatory Compliance
- EMA XEVMPD
- Data Governance
- KPI Reporting
- Cross-functional Collaboration
Who Can Apply?
Eligible Degrees (One Line):
B.Pharm, M.Pharm, M.Sc, B.Sc, Biotechnology, Microbiology, Biochemistry, Life Sciences, Pharmaceutical Sciences
Salary (Expected)
Based on similar Regulatory Operations roles in Mumbai:
- Estimated CTC: ₹8,00,000 – ₹13,00,000 per annum
(Actual compensation will depend on experience, skills, and company policies.)
Why Join Abbott?
- Work with a globally recognized healthcare leader.
- Exposure to international regulatory operations.
- Opportunity to work with global regulatory teams.
- Career growth in Regulatory Affairs and Regulatory Operations.
- Strong learning and development environment.
- Competitive compensation and employee benefits.
How to Apply
