RA Officer
2 - 4 Years of Experience
Not disclosed 
Full TimeImpulse Pharma Pvt Ltd
Boisar, Maharashtra, India
Posted on 05-04-2024
3 Vacancies
Description
- Prepare, submit, and manage regulatory filings and submissions to regulatory agencies, including marketing authorization applications, product registrations, and regulatory dossiers.
- Ensure that regulatory submissions are complete, accurate, and timely, and comply with regulatory requirements and guidelines.
- Obtain product registrations, licenses, and approvals from regulatory agencies for new product launches and changes to existing products.
- Monitor the status of regulatory applications and respond to requests for additional information or clarification from regulatory agencies.
- Maintain up-to-date knowledge of relevant regulations, guidelines, and standards governing the industry and products.
- Interpret regulatory requirements and assess the impact on product development, manufacturing, labeling, and distribution activities.
- Develop and implement regulatory strategies to ensure compliance with applicable regulations and standards.
- Review and approve product labeling, packaging, and promotional materials to ensure compliance with regulatory requirements, including labeling regulations, product claims, and warnings.
- Coordinate the review and approval of labeling and packaging changes with internal stakeholders and regulatory agencies.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Preferred Education
MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)
Key Skills
Regulatory SubmissionsProduct Registration and ApprovalsRegulatory ComplianceLabeling and Packaging ComplianceQuality Management Systems
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