Regulatory Affairs Manager Position at Abbott- Apply before 30th March 2025

Company: Abbott
Location: Mumbai, India
Industry: Pharma / Healthcare / Clinical Research
Functional Area: Regulatory Affairs
Application Deadline: 30th March 2025

About Abbott:

Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. With a portfolio of life-changing technologies spanning diagnostics, medical devices, nutritionals, and branded generic medicines, Abbott operates in over 160 countries with 109,000 employees worldwide.

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Job Role: Manager – Regulatory Affairs

Key Responsibilities:

• Regulatory Compliance: Ensure adherence to national regulations, guidelines, and internal policies related to FSSAI, Ayurvedic, and Drug Products.
• Product Regulatory Strategy: Provide regulatory pathways for new product introductions across FSSAI, Ayurvedic, and Drug product categories.
• Documentation & Compliance:
  • Review Draft Text Matter (DTM) for FSSAI products.
  • Evaluate product compositions (RDA limits) and health claims for FSSAI and AYUSH product labeling.
  • Maintain FSSAI licenses, including submission of annual returns to the regulatory authority.
• Regulatory Liaison & Updates:
  • Communicate new FSSAI and AYUSH regulations and guidelines to cross-functional teams (CFTs).
  • Engage with regulatory authorities on FSSAI product-related matters.
• Dossier Preparation & Filing:
  • Provide technical inputs on reviewing CMC data for CDSCO and State dossiers.
  • Handle SUGAM filings for CDSCO, from initial application to approval.
  • Respond to queries from CDSCO and FSSAI on submitted applications.
• Regulatory Support for Marketing & Product Launches:
  • Review and approve promotional materials for Nutraceutical and Ayurvedic products.
  • Provide regulatory support to ensure timely new product launches in FSSAI, Ayurvedic, and Drug categories.

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Qualifications & Skills:

• Educational Background: Bachelor’s / Master’s degree in Pharmacy, Life Sciences, or related field.
• Experience: 5+ years of experience in Regulatory Affairs within the pharmaceutical, nutraceutical, or healthcare industry.
• Technical Expertise: Knowledge of FSSAI, AYUSH, and CDSCO regulatory requirements and processes.
• Soft Skills: Strong communication, documentation, and collaboration abilities to work with regulatory authorities and cross-functional teams.

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Why Join Abbott?

• Work with a global leader in healthcare innovation.
• Be part of an organization that impacts lives worldwide.
• Opportunity to drive regulatory strategies for pioneering healthcare products.

🔗 Apply Now! Applications close on 30th March 2025.