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    • Manager Regulatory Affairs - Mumbai - Abbott Laboratories

    Abbott Laboratories
    Abbott Laboratories Mumbai

    3 weeks ago

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    Description

    Regulatory Affairs Manager

    This role provides support to the regulatory department, ensuring efficient and compliant business processes and environment. The successful candidate will execute regulatory tasks, partner across business functions, and provide technical leadership to business units.

    Main Responsibilities:

    • Ensure compliance with applicable corporate and divisional policies, procedures, and regulatory SOPs.
    • Assist in Regulatory SOP development and/or review.
    • Provide regulatory input to product lifecycle planning.
    • Assist in developing regulatory strategy and updating it based on regulatory changes.
    • Interpret and apply regulatory requirements.
    • Understand, investigate, and evaluate regulatory history/background of product class.
    • Determine trade issues to anticipate regulatory obstacles.
    • Participate in risk-benefit analysis for regulatory compliance.

    Key Qualifications:

    • Bachelor's degree in science or equivalent field (nutrition, dietetics, biology, chemistry, pharmacy, pharmacology, microbiology, or medical technology).
    • Additional tertiary qualifications in business management highly desirable.
    • 8-10 years of experience in regulatory affairs preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area.
    • 3-4 years of experience in a regulated industry (e.g., nutritionals, medical/pharmaceutical products).

    Desirable Skills:

    • Regulatory knowledge of GxPs (GMPs, GLPs, GCPs).
    • Principles and requirements of promotion, advertising, and labeling.
    • Familiarity with food/pharmaceutical regulations in India/Asia is an added advantage.
    • Strong communication skills, ability to negotiate with people from various disciplines, organizations, and cultures.
    • Proficient computer skills.
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