Regulatory Affairs Manager - Brazil Market Specialist

Job Summary

Regulatory Affairs Manager Brazil Market Specialist

Key Responsibilities

1. Regulatory Strategy & Compliance

• Develop and execute regulatory strategies for product registrations in Brazil.
  
• Ensure full compliance with

  ANVISA regulations

  , guidelines, and national requirements.
• Monitor regulatory changes in Brazil and update internal teams on impact and requirements.
  
• Conduct regulatory risk assessments for new and existing products.
  

2. Dossier Preparation & Submission

• Prepare, review, and submit dossiers (CMC, QA, Clinical, Non-clinical) for ANVISA approvals.
  
• Coordinate with internal teams to ensure timely and high-quality documentation.
  
• Manage renewals, variations, amendments, and post-approval commitments.
  
• Oversee GMP certification submissions and audits (if applicable).
  

3. Cross-functional Coordination

• Collaborate with Quality, R&D, Supply Chain, Packaging, Marketing, and International Business teams for regulatory accuracy.
  
• Liaise with local Brazilian agents, partners, and distributors for regulatory filings and follow-ups.
  
• Support product launches and ensure labeling, artwork, and packaging compliance.
  

4. Regulatory Maintenance & Lifecycle Management

• Oversee product maintenance: renewals, artwork updates, formulation changes, stability studies, etc.
  
• Manage regulatory compliance during manufacturing site changes or technology transfers.
  
• Maintain regulatory databases and documentation for the Brazil portfolio.
  

5. External Coordination

• Act as primary contact for ANVISA-related communication through local partners.
  
• Coordinate with third-party consultants, testing laboratories, and translation agencies.
  
• Support internal and external audits related to Brazil regulatory matters.
  

Qualifications & Skills

Education

• Bachelors or Masters degree in

  Pharmacy, Life Sciences, Chemistry, Biotechnology

  , or related field.

Experience

• 510 years

  of regulatory affairs experience in the pharmaceutical or healthcare industry.

• Mandatory experience

  with

  Brazil (ANVISA) regulatory processes

  .
• Experience in dossier preparation (CTD format ideal), registrations, renewals, and variations.
  

Technical Skills

• Strong knowledge of

  ANVISA laws, RDCs, and regulatory pathways

  .
• Familiarity with GMP, quality systems, and international regulatory standards.
  
• Proficient in submission planning, document review, and compliance evaluation.
  

Soft Skills

• Strong communication skills (English mandatory; Portuguese is an advantage).
  
• Excellent coordination, time management, and problem-solving abilities.
  
• Ability to work independently and manage multiple submissions simultaneously.
  

Key Deliverables

• Timely and successful ANVISA approvals.
  
• Zero non-compliance observations for Brazil submissions.
  
• Up-to-date regulatory documentation for all Brazil products.
  
• Strong stakeholder communication and efficient lifecycle management.

Location - Malad - Mumbai

Salary open for right candidate

Interested candidate please mail me your cv on hr@archerchem.com or what's app your cv on 9028871352.