Officer/ Sr. Officer - Regulatory Affairs (formulations) ROW/SEA

RESPONSIBILITIES

• Coordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets.
• Coordination with the customer at various registration stages to obtain approval.
• Analyze the molecule and determination for need of Bioequivalence or bio waiver studies.
• Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients.
• Review and approve the artworks as per Brazil and Canada market regulations.
• Interpretate deficiencies received compile and submission responses within the stipulated time frame.
• Maintenance of tracker for submission and deadline for responses and coordination with stakeholders to submit responses within stipulated deadlines.

DESIRED SKILLS

• Good knowledge of Registration requirements in ROW market.
• Experience in submission of generic medicine dossiers to the ROW market.
• Good technical knowledge, review skills and understanding of regulatory submissions
• Strong knowledge of CTD/ ACTD requirements for submission of dossiers to SEA , ME & AFRICA markets.
• Good analytical and problem-solving skills.
• Ability to try new approaches when faced with challenges.
• Should have a good analytical and learning attitude.
• Proactive to submission of response to any queries.
• Good communication skills.