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We are a leading health care company with the following areas of focus: Branded Generics, Active Pharmaceutical Ingredients (APIs & Formulation), and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by the export of APIs & Formulations and Branded generics.
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Position: Sr Executive – Regulatory AffairsÂ
Location: Govandi, Mumbai, Maharashtra
Job Description:
- Good understanding of EU Regulations, EU Procedural Guidance, and ICH Guidelines.
- Compilation and submission of high-quality registration dossiers in eCTD format as per current EU & ICH guidelines for filing application with various Regulatory Agencies in
- European continent especially DCP and National procedures
- Thorough Assessment and timely responses (within agreed timelines) of queries raised by various Regulatory Agencies in the European continent
- Basic understanding of Variation guidance and compilation of variation packages for filing.
- Co-ordinate, Collate and Conduct a high-quality review of relevant standard technical documentation like specification, stability, product development report, method validations, sterility assurance package, etc., BMR, BPR as per the ICH & European requirements.
- Knowledge of Medical Device Regulations in Europe
- Handling of change control proposals and if the required implementation of changes in licenses through variation and notification
- Basic pharmacovigilance knowledge for Europe.
- Basic knowledge of eCTD software.
- Effective communication and writing skills. self-initiator and optimistic
- Team player
Qualification: B.Pharma/M.Pharma
Experience: 4-6 Years
Salary: Negotiable
Contact Details:
Ms. Vaishali Pokar
hrd@usv.in
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