Assistant Manager – Regulatory Affairs -(PHR/1041/1)

The Assistant Manager – Regulatory Affairs will be responsible for managing regulatory submissions, maintaining compliance with DRAP requirements, coordinating product registration activities, and ensuring all regulatory documentation is prepared and submitted accurately and within required timelines.

• Prepare and submit registration dossiers through DRAP’s online system in a timely and accurate manner.

• Manage, maintain, and update records on the DRAP online portal.

• Handle product registration renewals and ensure compliance with renewal requirements.

• Review and update package inserts, leaflets, and labeling text in accordance with regulatory standards.

• Prepare lot release applications, pricing documentation, and related regulatory files.

• Coordinate with internal departments to collect required documents and information for submissions.

• Monitor regulatory deadlines and ensure timely completion of all assigned tasks.

• Maintain organized records of all submissions, approvals, correspondence, and regulatory documents.

• Assist in responding to regulatory queries and observations from DRAP.

• Support the implementation of regulatory compliance initiatives and process improvements.

• Strong analytical and problem-solving abilities.

• Effective presentation and communication skills.

• Excellent attention to detail and documentation management.

• Ability to manage multiple regulatory activities simultaneously.

• Strong organizational and coordination skills.

• Solid understanding of DRAP regulations, policies, and submission procedures.

• Knowledge of pharmaceutical regulatory frameworks and compliance requirements.

• Familiarity with product registration, renewals, lot release, and pricing documentation processes.

• Experience working with DRAP online systems and regulatory documentation.

• Pharm-D (Doctor of Pharmacy) or a related technical/professional degree.

• Additional certifications or training in regulatory affairs will be considered an advantage.

• Experience in pharmaceutical regulatory affairs.

• Hands-on experience with DRAP submissions and regulatory documentation.

• Exposure to product registration and compliance management activities.