Assistant Manager - Regulatory Affairs (Brazil)

Essential skills and experience:

• The incumbent must have min. 10 years experience in the pharmaceutical industry with a minimum of 6-8 years’ experience handling Regulatory compliance across the Brazil market.
• Develop and execute regulatory strategies for new registrations in Brazil market.
• Provide regulatory input during product development, CMC, labelling, 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.

Other responsibilities:

• Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field.
• 6–8+ 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.