Assistant Manager - RA Brazil

Umedica Labs; Navi Mumbai; On-site; INR 1,000,000 - 1,400,000; Full time

Job summary

Umedica Labs is seeking an experienced regulatory professional to develop strategies for new registrations in Brazil. The candidate will manage ANVISA submissions and ensure compliance with Brazilian regulations.

The ideal applicant has 8-10+ years in pharmaceuticals with strong knowledge of regulatory frameworks and CTD/eCTD structure. Interested candidates can apply via email.

Qualifications

• 8-10+ years of regulatory experience in pharmaceuticals with hands-on ANVISA submissions.
• Strong knowledge of Brazilian regulatory framework.
• Proficiency with CTD/eCTD structure.

Responsibilities

• Develop and execute regulatory strategies for new registrations in Brazil market.
• Prepare and submit applications via Brazil-ANVISA systems.
• Ensure compliance with Brazil labeling requirements.

Skills

Regulatory strategy development

Project management

Cross-functional communication

Attention to detail

Education

Bachelors/Masters in Pharmacy, Life Sciences or related field

Job description

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: new 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 [e-mail]