Pharm'Up 
HOF Pharmaceuticals Limited has announced an opening for the position of Senior Executive – International Regulatory Affairs at their Thaltej, Ahmedabad facility. The company specializes in manufacturing and exporting finished dosage formulations, including tablets, capsules, and oral liquids.
Position Overview
- Role: Senior Executive – Regulatory Affairs (International)
- Company: HOF Pharmaceuticals Limited
- Department: International Regulatory Affairs
- Location: Thaltej, Ahmedabad, Gujarat
- Experience Required: 7 to 8 Years (Specialized in RoW / Emerging Markets)
- Education: B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or related disciplines
- Application Mode: Email resume to hr@hofpharma.com
Key Responsibilities
- Dossier Preparation & Submission: Compile, review, and assemble technical regulatory dossiers in CTD, ACTD, and eCTD formats for product registrations across global emerging markets.
- Lifecycle Management: Manage post-approval submissions, product renewals, variations, and country-specific regulatory maintenance across assigned international territories.
- Cross-Functional Coordination: Collaborate closely with R&D, Quality Assurance (QA), Quality Control (QC), Production, Pharmacovigilance, and Supply Chain teams to source technical documentation and bridge data gaps.
- Query Resolution & Compliance: Track and formulate comprehensive responses to regulatory authority deficiencies and clarification requests within stipulated agency timelines.
- Regulatory Intelligence: Monitor regional regulatory updates across target geographies in Asia, Africa, and LATAM to maintain full compliance with evolving health authority mandates.
Candidate Profile & Qualifications
- Experience: 7 to 8 years of direct hands-on experience handling Rest of World (RoW) and emerging market registrations.
- Technical Mastery: Strong command over CTD/ACTD structure, technical document evaluation, and gap analysis for solid orals and liquid formulations.
- Regional Exposure: Proven track record handling regulatory submissions across Asia, Africa, LATAM, or CIS markets.
- Skills: Excellent technical documentation capability, regulatory problem-solving, project tracking, and cross-departmental communication.
How to Apply
Interested candidates with relevant expertise in international regulatory affairs can send their updated curriculum vitae to:
- Email: hr@hofpharma.com
- Subject Line Suggestion: Application for Regulatory Affairs – Senior Executive (RoW)
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