RA - Officer / Executive / Sr. Executive

RA US Market

Position Overview: We are seeking a Regulatory Affairs Specialist with up to 3 years of experience in CMC (Chemistry, Manufacturing, and Controls) aspects for pharmaceutical products. The role involves preparation, review, and submission of dossiers in compliance with regulatory requirements across the US, EU, and Brazil markets.

1. Regulatory Submissions:

• Prepare, compile, and review regulatory dossiers (e.g., ANDA, NDA, variations, renewals) for the US and EU markets in eCTD and non-eCTD formats.
• Support registration processes for the Brazil, Canada and AU markets, ensuring alignment with ANVISA, HC, TGA requirements.

2. Compliance:

• Ensure compliance with applicable regulatory guidelines, such as FDA, EMA, HC, TGA and ANVISA regulations.
• Monitor regulatory changes and provide timely updates to internal stakeholders.

3. Cross-functional Collaboration:

• Work closely with QA, QC, R&D, and manufacturing teams to gather necessary documentation for regulatory submissions.
• Act as a liaison with external partners, consultants, and regulatory agencies.

4. Regulatory Strategy:

• Contribute to regulatory strategies to expedite product approvals and maintain compliance.
• Address regulatory queries and deficiencies raised by authorities within the specified timelines.

5. Post-approval Maintenance:

• Manage post-approval activities, including labeling updates, variations, and renewals for the assigned markets.

6. Documentation and Database Management:

• Maintain regulatory databases and ensure accurate and up-to-date records of submissions and approvals.

RA ROW Market

• Dossier Compilation Experience in compiling dossiers for multiple countries, ensuring compliance with diverse regulatory frameworks.
• Regulatory Coordination Ability to coordinate with cross?functional teams (R&D, QA, QC, Production) to gather required data and documents.
• Routine RA Activities Skilled in managing and completing routine Regulatory Affairs tasks such as submissions, renewals, and variations.
• Query Resolution – Hands?on experience in addressing and resolving regulatory authority queries effectively.
• Documentation & Compliance – Strong knowledge of international guidelines and ability to maintain accurate, audit?ready documentation.