XL Laboratories hiring Regulatory Affairs Sr. officer , Executive , Delhi , M Pharma

XL Laboratories Recruitment - Job vacancies
    • Full Time
    • delhi
    • 25000 INR / Month

    XL Laboratories is seeking talented individuals to join our Regulatory Affairs team in Delhi. If you have an M Pharma qualification and 3 to 5 years of experience in regulatory affairs, this is an excellent opportunity to advance your career in a dynamic pharmaceutical environment.

    Job Vacancies: Regulatory Affairs Sr. Officer, Executive

    Location: Delhi

    Qualifications and Experience:

    • Education: M Pharmacy
    • Experience: 3 to 5 years in regulatory affairs
    • Familiarity with EU, UK, and ANZ regulatory filings
    • Strong knowledge of ICH Guidelines
    • Excellent oral and written communication skills

    Job Responsibilities: As a Regulatory Affairs Sr. Officer, Executive at XL Laboratories, your responsibilities will include:

    1. Handling EU, UK, and ANZ regulatory filings and maintaining Marketing Authorizations (MAs).
    2. Conducting regulatory review and compiling technical documentation dossiers for various markets, ensuring compliance with regulations and guidelines.
    3. Performing adequacy reviews and gap analyses of CTD dossiers and technical documentation.
    4. Preparation and review of registration dossiers (m1-m5) according to country-specific regulatory requirements.
    5. Updating dossiers based on queries from regulatory authorities.

    How to Apply: If you are interested in joining our team, please share your resume via email at [email protected] or through WhatsApp at 9896398522.

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