EM Regulatory Operations Specialist
Location: Mumbai Development Center (EPD), Mumbai, Maharashtra, India
Function: Regulatory Affairs – Emerging Markets (EM)
Employment Type: Full-Time
Company Overview
Abbott Laboratories is a global healthcare leader committed to delivering high-quality pharmaceutical and established products through strong regulatory governance and operational excellence. The Mumbai Development Center plays a critical role in supporting Emerging Markets regulatory operations.
Role Overview
The EM Regulatory Operations Specialist provides operational and data management support to Emerging Market (EM) Regional and Local Regulatory teams. This role focuses on regulatory database management, compliance documentation, publishing support, and process optimization to ensure accurate, timely, and compliant regulatory submissions.
This opportunity is ideal for professionals seeking Regulatory Operations jobs in Mumbai within a structured global pharmaceutical environment.
Key Responsibilities
Regulatory Operations & Data Management
Perform operational tasks aligned with company policies, SOPs, and local regulatory requirements.
Enter, upload, and maintain data and documentation in approved regulatory databases.
Conduct compliance checks to ensure data accuracy and completeness.
Provide compilation and publishing support for regulatory submissions.
Support documentation archiving in accordance with record retention policies.
Cross-Functional Collaboration
Interact with internal stakeholders to ensure effective communication and alignment.
Support timely delivery of regulatory operational milestones.
Demonstrate effective coordination and follow-up with relevant teams.
Compliance & Governance
Ensure adherence to regulatory requirements and internal compliance standards.
Maintain awareness of evolving legislation and implement updates as necessary.
Support continuous monitoring of compliance processes.
Process Improvement & SOP Development
Contribute to harmonization and streamlining of regulatory operational processes.
Support development of SOPs and deliver training where applicable.
Identify opportunities for continuous improvement in regulatory workflows.
Technical & Professional Competencies
Technical Knowledge
Strong understanding of regulatory systems, document management tools, and databases.
General awareness of global and regional regulatory requirements.
Proficiency in MS Office tools including Word, Excel, and PowerPoint.
Integrity & Quality Orientation
Deliver high-quality, accurate results within defined timelines.
Maintain consistency, transparency, and attention to detail.
Adaptability & Prioritization
Manage multiple priorities effectively under tight deadlines.
Demonstrate flexibility and problem-solving capability.
Initiative & Continuous Improvement
Proactively identify and mitigate potential risks.
Seek feedback and contribute to ongoing performance improvements.
Educational Qualifications
Bachelor’s Degree in Pharmacy, Biology, Chemistry, Pharmacology, or related Life Sciences discipline.
Experience Required
Minimum 2–4 years of relevant experience in Regulatory Operations within the pharmaceutical industry.
Hands-on experience with regulatory databases and document management systems preferred.
Strong attention to detail, communication skills, and compliance mindset.
Why Join Abbott?
Opportunity to support Emerging Markets regulatory operations within a global pharmaceutical organization.
Exposure to international regulatory documentation and database systems.
Career progression within Regulatory Affairs and Global Operations.
SEO & GEO Keywords: EM Regulatory Operations Specialist Mumbai, Regulatory Operations Jobs India, Pharma Regulatory Database Jobs Mumbai, Emerging Markets Regulatory Affairs Careers, Regulatory Publishing Jobs India, Abbott Regulatory Operations Jobs Mumbai.
This role is suited for regulatory operations professionals seeking opportunities in Mumbai with exposure to Emerging Markets regulatory workflows, compliance management, and global pharmaceutical regulatory systems.
Uttar Pradesh :
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Delhi | India | New Delhi | PAN-India |Assam :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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