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    • Regulatory Affairs Manager - Palakkad - One of Top Leading Pharma Company

    One of Top Leading Pharma Company
    One of Top Leading Pharma Company Palakkad

    2 weeks ago

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    Description

    Regulatory Affairs – OSD (ROW Markets)

    We are seeking a skilled professional to fill the role of Officer/Executives/AM/Manager/Sr Manager, with a total of 10 roles available in our Navi Mumbai location.

    The ideal candidate will have between 5 to 18 years of experience in the industry and possess a strong background in Regulatory Affairs – Oral Solid Dosage (OSD) for Rest of the World (ROW) markets.

    Key Responsibilities:

    • Regulatory Dossier Preparation: Prepare, review, and submit regulatory dossiers for Oral Solid Dosage (OSD) products in ROW markets.
    • Compliance Management: Ensure compliance with country-specific regulatory requirements and guidelines.
    • End-to-End Submissions: Handle end-to-end regulatory submissions, including new product registrations, renewals, and post-approval changes.
    • International Liaison: Liaise with international regulatory agencies and maintain updated knowledge of evolving regulatory landscapes.
    • Cross-Functional Collaboration: Work closely with cross-functional teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure regulatory compliance.
    • Regulatory Queries: Manage regulatory queries and deficiency responses from health authorities in a timely manner.
    • Regulatory Strategies: Evaluate and implement regulatory strategies for product lifecycle management.
    • Guideline Compliance: Ensure compliance with ICH, WHO, and other regulatory guidelines applicable to ROW markets.

    Key Requirements:

    • Education: M.Pharm / B.Pharm / M.Sc in a relevant field.
    • Experience: 5 to 15 years in Regulatory Affairs for Oral Solid Dosage (OSD) formulations.
    • Industry Experience: Experience working with top pharmaceutical companies handling ROW markets.
    • Regulatory Knowledge: Strong knowledge of regulatory requirements in ROW countries, including dossier preparation (CTD/eCTD).
    • Preferred Qualifications: Experience in China and South Africa markets, hands-on experience with product registrations, renewals, and variations.
    • Communication Skills: Excellent communication and documentation skills.

    Apply by sharing your CV.

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