Assistant Regulatory Officer

3 weeks ago

Vadodara, India Kaapro Management Solutions Full time

Opening: 1 Nos.- Job ID: 60909- Employment Type: Full Time- Reference:
- Work Experience: 4.0 Year(s) To 5.0 Year(s)- CTC Salary: 3.00 LPA TO 4.00 LPA- Function: Pharma / Biotech / Healthcare / Medical / R&D- Industry: Pharma/Biotech/Clinical Research- Qualification: B.Pharma - Pharmacy; M.Pharma - Pharmacy- Location:

- Vadodara/baroda

Posted On: 24th May, 2023
**Duties and Responsibilities**:

- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
- Timely compile materials for license renewals, updates and registrations
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Review labeling and labels for compliance with regulatory requirements
- Review changes to existing products and SOPs to define the requirements for regulatory submissions
- Provide the regulatory reviews of customer complaints and define the regulatory re-portability
- Responsible for timely registration of the facility
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes
- Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
- Salary shall be commensurate to experience and qualification.

Working location shall be around 20 Km from Vadodara and company transport will be available.

**Key Skills**:

- Regulatory Affairs
- Regulatory Compliance
- Dossier Registration
- Ctd
- Actd

**Company Profile**:
Our Client is a reputed pharma company based at Vadodara

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