Pharm'Up 
Swiss Parenterals, a premier pharmaceutical company with over 25 years of expertise in sterile dosage forms and a presence in 80+ countries, is hiring for senior-level Regulatory Affairs positions. These roles are critical for managing global strategies across ROW (Rest of World), UK, and European markets.
Vacancy Summary
| Feature | Details |
| Department | Regulatory Affairs |
| Experience | 15 to 20 Years (Relevant Industry Experience) |
| Qualification | B.Pharm / M.Pharm / Ph.D |
| Market Focus | EU, UK, ROW (Global) |
| End Date | 10th February 2026 |
Specialized Leadership Openings
1. RA Head (Injectables)
- Dossier Management: Leading strategy for CTD/eCTD submissions specifically for sterile injectables.
- Agency Interface: Primary contact for EMA and MHRA.
- Lifecycle Management: Handling variations, renewals, and PSURs (Periodic Safety Update Reports).
- Audit Support: Guiding regulatory inspections for sterile manufacturing sites.
2. Injectable Lead
- Technical Review: Managing CTD modules with a focus on aseptic processing and stability.
- Coordination: Aligning with CMC (Chemistry, Manufacturing, and Controls) and QA teams for dossier readiness.
- Query Resolution: Addressing complex agency questions regarding sterility and shelf-life.
3. Oral Solid Dosage (OSD) Lead
- Product Range: Strategy for tablets, capsules, and modified-release products.
- CMC Compliance: Ensuring documentation aligns with evolving EU and ROW guidelines.
- Lifecycle: Overseeing line extensions and post-approval supplements.
4. Biotech Lead
- Therapeutic Areas: Global strategy for Biologics and Biosimilars.
- Submissions: Executing regulatory pathways for clinical and commercial biotech dossiers.
- Clinical Oversight: Supporting regulatory pathways for clinical trials and WHO frameworks.
Key Competencies
- Regulatory Intelligence: Monitoring evolving global guidelines for biologics and sterile products.
- Cross-functional Synergy: Coordinating with R&D, Clinical, and Manufacturing teams to ensure seamless compliance.
- Expertise in eCTD: High proficiency in electronic Common Technical Document formats for global health agencies.
How to Apply
Experienced candidates who match the high-level requirements for these roles are invited to send their resumes to:
Emails: hroffice1@swiss.in AND hroffice@swiss.in
Deadline: February 10, 2026
About the Author
