HomeRegulatory AffairsEmerging Market Regulatory Operations Specialist | Abbott Laboratories | Mumbai

Emerging Market Regulatory Operations Specialist | Abbott Laboratories | Mumbai

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Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

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The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Position: Emerging Market Regulatory Operations Specialist

Location: BKC Building, Mumbai, Maharashtra, India

Job Description:

Primary Job Function :

This is a newly created position to 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.

The overall scope consists of providing operational support to EM Regional and Local Regulatory Teams, primarily in:

1. 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.

2. Relationships & Cross-Functional teamwork

  • Interacts with relevant stakeholders to ensure effective communication and continuous awareness
  • Ensures continuous alignment and timely delivery

3. Coordination

  • Demonstrates effective planning, follow up and coordination with relevant stakeholders
  • Provides timely and high-quality support as per the internal procedure

4. 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

5. 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 a good understanding of systems and tools
  • Shows general understanding of regulatory requirements

Integrity

  • Delivers high-quality results
  • Meets agreed with 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 the 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 – 4 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)

Qualification: B.Pharma/Lifescience with Diploma in Regulatory Affairs(Preferable)

Experience: 5- 7 years of relevant work experience

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