Executive/Sr Executive – Regulatory Affairs (Europe & Australia Markets)
Location: Bengaluru, Karnataka, India | Job Type: Full-time, On-site
1. Job Description
Lyrus, a leading pharmaceutical company, is hiring an experienced Regulatory Affairs Executive/Sr Executive to manage dossier submissions for Europe (EU), Australia (TGA), and other semi-regulated markets. The role involves:
- Dossier preparation & review (Modules 1-5) for EU & Australia.
- Handling e-CTD software and regulatory databases.
- Coordinating with cross-functional teams for technical documents (specifications, AMV, CDP, stability reports).
- Preparing and reviewing product labels for EU & other markets.
- Managing variation sequences and responding to regulatory queries.
- Ensuring compliance with EU, TGA, US, South Africa, GCC, and ROW regulations (additional advantage).
2. About the Hiring Company – Lyrus
Lyrus is a reputed pharmaceutical firm specializing in global regulatory compliance and drug submissions. With a strong presence in EU, Australia, and emerging markets, the company is known for its innovation and adherence to quality standards.
3. Eligibility Criteria
- Education: Graduation/Post-graduation in Pharmacy, Life Sciences, or related fields.
- Experience: Minimum 4+ years in Regulatory Affairs, specifically in EU & Australia dossier handling.
- Technical Skills:
- Hands-on experience in e-CTD software.
- Expertise in dossier compilation (M1-M5).
- Knowledge of US, South Africa, GCC markets (preferred).
- Soft Skills: Strong communication, teamwork, and deadline-driven approach.
4. How to Apply
Interested candidates meeting the criteria can apply via:
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- Email: Send your updated resume to hr@lyruslife.com with the subject line “Application for Sr Executive – Regulatory Affairs”.
- Easy Apply: Submit through the job portal (if applicable).
