Abbott Regulatory Operations Specialist – Job Role in Mumbai, Apply Now!
Abbott, a global leader in healthcare and medical innovation, is looking for a Regulatory Operations Specialist in Mumbai, India. This role supports regulatory compliance, data management, and operational tasks within Emerging Markets (EM). If you have 2+ years of experience in regulatory operations, apply now to join a company committed to improving lives worldwide!
- Job Title: EM Regulatory Operations Specialist
- Location: India > Mumbai : BKC Building
- Category: Regulatory Affairs
About Abbott
Abbott is a global healthcare company that develops life-changing technologies in medical devices, diagnostics, pharmaceuticals, and nutrition. With a presence in over 160 countries, Abbott is committed to innovation and improving the quality of life for millions.
Primary Job Function
Support regulatory operational tasks within the Emerging Markets (EM) to ensure activities are completed consistently in a timely manner in accordance with Abbott policies, procedures and local regulations.
Overall Scope
Overall scope consists of providing operational support to EM Regional and Local Regulatory Teams, primarily in:
- Operational tasks in line with Abbott policies, procedures and local regulations
- Data management support into approved databases
- Data entry into approved databases
- Upload of data and documents into approved databases
- Compliance check of documents to ensure data accuracy
- Compilation support of data and documents into approved databases
- Publishing support
- Other administrative and operational tasks as per requirements
- Relationships & Cross Functional team work
- Interacts with relevant stakeholders to ensure effective communication and continuous awareness
- Ensures continuous alignment and timely delivery
- Coordination
- Demonstrates effective planning, follow up and co-ordination with relevant stakeholders
- Provides timely and high-quality support as per internal procedure
- Compliance
- Ensures continuous compliance in alignment with Abbott procedures and regulations
- Maintains awareness of legislation and implement changes as relevant
- Ensure compliance with record retention (archiving) policy
- Process Improvement
- Supports in streamlining and harmonizing relevant processes
- Creates SOPs, delivers training as applicable
- Identifies opportunities and suggestions for continuous improvements
Core Competencies
- Technical competency
- Demonstrates technical knowledge and good understanding of systems and tools
- Shows general understanding of regulatory requirements
- Integrity
- Delivers high quality results
- Meets agreed deadlines
- Displays consistency
- Adaptability
- Shows flexibility and ability to work under pressure
- Reacts quickly to solve problems and issues when they arise
- Manages priorities and align with manager in case of conflicts/priorities
- Initiative
- Attempts to anticipate, mitigate issues and proactively flag risks
- Shows problem solving skills
- Seeks for performance continuous improvements
Education/Qualifications/Experience
- Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, or related subject
- Minimum 2 years of relevant experience in regulatory operations
- Detailed oriented, communication, compliance and process Improvement skills.
- Computer Knowledge: Knowledge of the Office package (Ms Word, Ms Excel, Ms Power Point
Keywords: Abbott, EM Regulatory Operations Specialist, Regulatory Affairs, Mumbai, Regulatory Operations, Compliance, Process Improvement
