Role & responsibilities
- Develop and execute regulatory strategies for new registrations in Brazil market.
- Provide regulatory input during product development, CMC, labeling, and clinical/medical strategy discussions.
- Prepare/coordinate dossiers (CTD/eCTD) including Module 1-5 requirements.
- Compile, review, and submit applications via Brazil-ANVISA systems; track and respond to queries/deficiencies within defined timelines.
- Partner with CMC, Quality, Supply Chain, Medical, Pharmacovigilance, and Commercial to align regulatory strategy.
- Prepare, coordinate, and attend meetings with customer / ANVISA; support interactions with authorities as and when required.
- Ensure compliance with Brazil labeling requirements (SmPC/IFU/PIL), serialization/traceability, and artwork controls.
- Maintain up-to-date knowledge of Brazilian regulatory frameworks, guidance, and timelines.
- Ensure adherence to internal SOPs, GDP, data integrity, and audit-readiness.




- Maintain accurate submission trackers, registration databases, regulatory archives, and regulatory intelligence logs.

Preferred candidate profile
- Bachelors/Masters in Pharmacy, Life Sciences, or related field.
- 8-10+ years of regulatory experience in pharmaceuticals with hands-on ANVISA submissions.
- Strong knowledge of Brazilian regulatory framework: recent drug registration, generics, labeling, GMP certification alignment, AMV, stability, BE/CDP requirements etc.
- Proficiency with CTD/eCTD structure; understanding of CMC and PV interface.
- Excellent project management, attention to detail, and cross-functional communication skills.
- Candidates having South Africa, Latam, Emerging can also be considered.

*Interested candidates can apply or mail their updated resume on [email protected]*

📌 Assistant Manager (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai