Regulatory Affairs Strategist

1 day ago


Mumbai, Maharashtra, India Abbott Full time

Job Summary

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We are seeking an Experienced Regulatory Affairs Manager to join our team at Abbott.

About the Role

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This is an individual contributor role that works under limited supervision and applies subject matter knowledge in the area of Regulatory Affairs.

The ideal candidate will possess well-developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Key Responsibilities

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  • Interact with regulatory agencies to expedite approval of pending registration.">
  • Serve as a regulatory liaison throughout the product lifecycle.">
  • Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).">
  • Evaluate and advise on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.">
  • Maintain ongoing relationships with regulatory agencies to ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.">
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Requirements

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An Associate's Degree is required for this role.

Compensation and Benefits

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We offer a competitive salary range of $80,000 - $110,000 per year, depending on qualifications and experience.

Why Work with Us?

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At Abbott, we value our employees' contributions and offer a comprehensive benefits package, including health insurance, retirement savings, and paid time off.



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