Associate Regulatory Operations
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility / Qualifications
- Educational Requirements
- Experience Requirements
- Required Skills & Competencies
- Location & Salary
- Application Process
- Frequently Asked Questions
- Who is eligible to apply for this role?
- Is this role suitable for freshers?
- What kind of documents will I work on?
- Is this a global-facing role?
- Where is the job located?
- Additional SEO Title Options
- Summary Table
Associate Regulatory Operations – Life Sciences – Mumbai
Abbott hiring Associate Regulatory Operations in Mumbai. Life Sciences graduates with 3–5 years regulatory experience eligible.
Abbott is hiring an Associate Regulatory Operations professional for its Mumbai Development Center to strengthen its global regulatory documentation and submission operations. This role is ideal for experienced regulatory affairs professionals who have hands-on exposure to document operations, regulatory submissions, and compliance-driven environments within the pharmaceutical or healthcare industry. The position offers the opportunity to work closely with global regulatory teams, support high-impact submission activities, and contribute to process improvements that directly affect product approvals and patient safety worldwide.
Company Overview
Abbott is a global healthcare leader with a strong presence across pharmaceuticals, medical devices, diagnostics, and nutrition products. With operations in more than 160 countries, Abbott is known for its science-driven approach, robust regulatory compliance culture, and long-standing commitment to improving human health.
The Mumbai Development Center plays a critical role in supporting Abbott’s global regulatory and development functions. Teams based here work on high-value regulatory documentation, submission readiness, lifecycle management, and compliance activities that support product registrations across major global markets. Abbott’s regulatory ecosystem is built on accuracy, standardization, and adherence to evolving international regulatory requirements, making it a trusted name with health authorities worldwide.
Working at Abbott means being part of an organization that values integrity, quality, and continuous improvement. Regulatory Operations professionals at Abbott are not just document handlers. They are key contributors to successful submissions, regulatory intelligence, and long-term product sustainability.
Job Role & Responsibilities
The Associate Regulatory Operations role sits within the Regulatory Affairs function, specifically supporting Document Operations. The position focuses on the preparation, processing, quality control, and lifecycle management of regulatory submission documents using structured document management systems.
Key Responsibilities
- Process regulatory submission documents in line with internal Abbott standards and global regulatory authority requirements
- Use document management and publishing tools to prepare, format, and finalize submission-ready documents
- Perform detailed quality checks on own work and on documents prepared by other team members to ensure formatting, consistency, and compliance
- Ensure submission documents meet health authority expectations for structure, presentation, and technical accuracy
- Collaborate closely with Regulatory Affairs colleagues, Operations team members, and document publishers to meet submission timelines
- Support the assembly and delivery of high-quality regulatory submission packages within established deadlines
- Communicate effectively with global business partners and stakeholders across multiple time zones
- Contribute to ongoing regulatory operations activities as assigned by the department
- Support departmental projects related to document operations, compliance, and workflow optimization
- Assist and guide less experienced colleagues through knowledge sharing and on-the-job support
- Participate in setting internal standards and developing training materials related to document operations
- Contribute to process improvement initiatives, system enhancements, and optimization of document workflows
- Assist in troubleshooting issues related to document management software and operational processes
This role demands a strong understanding of regulatory documentation standards, attention to detail, and the ability to work in a fast-paced, deadline-driven environment where accuracy is non-negotiable.
Eligibility / Qualifications
Educational Requirements
Candidates must hold a graduation degree or higher in Life Sciences or related disciplines.
Relevant Courses (comma-separated):
B.Pharmacy, M.Pharmacy, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Pharmaceutical Sciences
Experience Requirements
- 3 to 5 years of experience in Regulatory Affairs, Regulatory Operations, R&D documentation, or related pharmaceutical functions
- Prior exposure to pharmaceutical regulatory submissions, labeling documents, or technical documentation
- Experience working in regulated environments governed by global health authority requirements
Required Skills & Competencies
- Strong familiarity with pharmaceutical regulatory or labeling documents
- Excellent verbal and written communication skills in English
- Hands-on experience with MS Word formatting for regulatory documents
- Practical experience using document management systems and publishing tools
- Ability to quickly learn and adapt to document management-based computer systems
- Strong process orientation with high attention to detail
- Ability to manage multiple priorities and re-prioritize work in response to changing business needs
- Comfortable working in fast-paced, collaborative team environments
- High level of accountability and commitment to quality
This role is best suited for regulatory professionals who enjoy structured work, value compliance, and take ownership of document quality.
Location & Salary
- Job Location: Mumbai Development Center, Mumbai, India
- Department: Regulatory Affairs – Document Operations
- Employment Type: Full-time
- Salary: Competitive and aligned with industry standards based on experience and skill level
Abbott offers a strong compensation structure, professional development opportunities, and exposure to global regulatory projects that enhance long-term career growth.
Application Process
Eligible candidates can apply directly through Abbott’s official career portal using the link below:
https://www.jobs.abbott/us/en/job/ABLAUS31138446ENUSEXTERNAL/Associate-Regulatory-Operations
Frequently Asked Questions
Who is eligible to apply for this role?
Life Sciences graduates with 3 to 5 years of experience in Regulatory Affairs, Regulatory Operations, or related pharmaceutical functions are eligible.
Is this role suitable for freshers?
No. This position requires prior regulatory or related industry experience.
What kind of documents will I work on?
You will work on regulatory submission documents, labeling content, and other compliance-driven documentation.
Is this a global-facing role?
Yes. The role involves collaboration with global regulatory teams and stakeholders.
Where is the job located?
The position is based at Abbott’s Mumbai Development Center.
Additional SEO Title Options
- Abbott Hiring Associate Regulatory Operations – Mumbai Regulatory Affairs Jobs
- Associate Regulatory Operations Vacancy at Abbott – Life Sciences Professionals
- Abbott Regulatory Affairs Careers – Associate Regulatory Operations Mumbai
Summary Table
| Company | Abbott |
|---|---|
| Vacancies | Associate Regulatory Operations |
| Required Education | B.Pharmacy, M.Pharmacy, Pharm.D, B.Sc, M.Sc Life Sciences |
| Experience | 3–5 Years |
To apply for this job please visit www.jobs.abbott.
