Job Title: Officer / Sr. Officer – Regulatory Affairs
Location: Ramamurthy Nagar, Bangalore
Company: Relicare Tech Services Private Limited
Job Overview:
Relicare Tech Services Private Limited is hiring passionate and skilled individuals for the position of Officer / Sr. Officer in the Regulatory Affairs department. This role focuses on dossier compilation, regulatory submissions, and quality document preparation for the South African Market and Rest of Africa (ROA) region. The ideal candidate should have a strong background in pharmaceutical sciences and regulatory documentation, ensuring compliance with international standards.
Key Responsibilities:
Dossier Compilation:
Compile and review CTD (Common Technical Document) dossiers and variations according to South African regulatory requirements.
Agency Communication:
Prepare high-quality responses to regulatory agency queries to ensure timely submission and approval.
Quality Assurance Support:
Prepare and review APQR (Annual Product Quality Review) summary reports to assist the QA team.
Cross-Functional Collaboration:
Liaise proactively with R&D, manufacturing sites, customers, and principals to gather necessary documents for timely dossier submissions.
Qualifications:
Education:
B. Pharm or M. Pharm degree required.
Experience:
2 to 4 years of relevant experience in regulatory affairs.
Strong understanding of South African Market and ROA regulatory requirements.
Skills:
Expertise in CTD dossier preparation and variation management.
Excellent document review and technical writing skills.
Ability to coordinate across multiple departments for timely dossier compilation.
Strong communication and organizational skills.
Application:
Interested candidates can email their CV to: Navaneetha.BShivanna@adcock.com
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