HomeRegulatory AffairsEmerging Market Regulatory CMC Specialist | Abbott Laboratories | Mumbai

Emerging Market Regulatory CMC 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 CMC Specialist

Location: BKC Building, Mumbai, Maharashtra, India

Job Description:

Primary Job Function :

This is a newly created position to support CMC activities for local and regional products within the Emerging Markets (EM) to ensure activities are completed consistently in a timely manner in accordance with Abbott’s policies, procedures and local regulations.

The overall scope consists of providing CMC support to Regional and Affiliate Product Leads, primarily in:

1. CMC writing for Local and Regional products

  • Drafts scientific CMC, and regulatory documents that conform to regional/local/global regulatory requirements, industry standards, and accepted templates.
  • Extracts and summarizes scientific information from development reports and identify details required for regulatory submissions.
  • Prepares coordinates and manages the review and approval of documents by:
    • Supporting the operation of the integrated review process
    • Performing comment reconciliation to address and resolve issues
    • Editing and creating updated drafts for the next phase of review in accordance with the established timelines
  • Complies with Abbott’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of Abbott

2. Relationships & Cross-Functional teamwork

  • Compiles and approves regulatory documents in collaboration with technical and operational stakeholders
  • Manages review and approval of regulatory documents; engages members of relevant stakeholders to address and resolve issues in accordance with established timelines.
  • Monitors and communicates actual versus planned regulatory activities and timelines
  • Identifies and communicates risks and issues impacting project progression
  • Maintains awareness of regulatory legislation and assesses its regional impact on business and Emerging Market Regulatory Affairs

3. Coordination

  • Builds and maintains strong working relationships with Regional and Affiliate Product Leads
  • Provides accurate feedback to colleagues

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. Strategy: 

  • Takes steps to identify, communicate, and mitigate Regulatory CMC risks

6. 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 PowerPoint)

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

Experience: 5- 7 years of relevant work experience

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