Asst. Manager/Manager - RA
Quality HR Services · Not specified · onsite · Posted 27d ago
Undisclosed15–20 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Job Summary
Position: Asst. Manager/Manager - RA
Location: Daman
Experience: 15 - 20 Years
Industries: Pharma
Responsibilities - Lead the Regulatory Affairs function and manage regulatory submissions for domestic and international markets.
- Prepare, review and submit CTD/eCTD dossiers, variations, renewals and regulatory responses.
- Coordinate with RD, QA, QC, Production and other departments for regulatory documentation.
- Handle regulatory submissions and approvals for new products, existing products and post-approval changes.
- Review product dossiers, technical documents, specifications, stability data and compliance documents.
- Manage regulatory queries and ensure timely responses to health authorities.
- Monitor changes in regulatory guidelines and requirements and ensure compliance.
- Support regulatory audits and inspections and coordinate responses to observations.
- Maintain regulatory databases, submission trackers and approval records.
- Lead and mentor the RA team and ensure timely completion of regulatory activities.
- Strong knowledge of Pharma Regulatory Affairs CTD/eCTD
- Experience in US/EU/ROW or regulated markets
- Expertise in regulatory submissions, variations renewals
- Strong knowledge of GMP and regulatory guidelines
- Excellent documentation and communication skills
- Strong coordination, leadership and problem-solving abilities
- Experience with ERP/eQMS and regulatory submission systems will be an added advantage
B.Pharm/M.Pharm/B.Sc/M.Sc - Chemistry
Key Skills - R&d
- Qa
- Qc
Sourced from naukri
Skills
QARegulatory AuditsRegulatory AffairsEctdregulatory submissionsauditsChemistryregulatory documentationERPCommunication SkillscomplianceQCPharma
About Quality HR Services
Quality HR Services
Recruitment
30
employees
2017
9 years old
Vapi, Gujarat
India
₹3.1L PA avg
Avg at Quality HR Services
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Quality HR Services
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