• Main Purpose of Job :

The main purpose of this role is to lead and manage the Regulatory Affairs department, ensuring adherence to regulatory standards, managing submissions, and facilitating market access for pharmaceutical products in alignment with the pharmaceutical industry.

• Functional Responsibilities :

• Regulatory Submissions: Prepare and submit dossiers for product registrations and approvals.

• Product Compliance: Ensure product compliance with local and international regulations.

• Documentation Management: Maintain accurate and up-to-date regulatory documentation.

• Regulatory Guidance: Provide regulatory guidance and support to cross-functional teams.

• Audits and Inspections: Prepare for and manage regulatory audits and inspections.

• Labeling and Packaging: Oversee regulatory compliance in product labeling and packaging.

• Performs other related duties and tasks as directed