Job Summary:

The Senior Regulatory Officer is responsible for leading and coordinating all regulatory, compliance, and pharmacovigilance activities to ensure that pharmaceutical products meet legal, safety, and quality standards. This role provides strategic oversight of regulatory submissions, quality assurance systems, and drug safety monitoring, while supporting cross-functional teams in achieving business and compliance objectives.

Key Responsibilities

Regulatory Compliance & Approvals

• Develop and implement strategies for obtaining regulatory approval for new pharmaceuticals and maintaining compliance for existing products.
• Manage and oversee the preparation and submission of regulatory documents (INDs, NDAs, MAAs, supplementary registrations).
• Liaise with regulatory authorities (e.g., Food and Drugs Division, Drug Inspectorate) to facilitate timely approvals and reduce delays.
• Maintain and update licensing, approvals databases, and regulatory documentation.
• Provide regulatory guidance to internal teams and external partners, including manufacturers, distributors, and customs officials.
• Monitor regulatory changes and communicate updates to stakeholders.

Key Responsibilities Cont’d:

Quality Assurance & Control

• Oversee the management of Standard Operating Procedures (SOPs), including training and change control.
• Conduct internal audits and coordinate supplier compliance audits.

Pharmacovigilance & Drug Safety

• Maintain a robust pharmacovigilance system at the local/national level.
• Ensure timely reporting of adverse drug reactions, medication errors, and special case safety reports.
• Screen national literature and regulatory updates for drug safety information.
• Ensure proper filing and communication of case-related correspondence.

Cross-Functional Collaboration

• Partner with R&D, Quality Assurance, Warehousing, Procurement, and Logistics to integrate regulatory requirements into operations.
• Support sales and marketing teams with compliance-related input to achieve business objectives.
• Provide feedback and reports to management and principals on regulatory and quality issues.

Administrative & Leadership Duties

• Manage performance metrics, prepare corrective action reports, and drive continuous improvement initiatives.
• Mentor and train junior regulatory staff.
• Ensure adherence to company policies, health and safety standards, and ethical guidelines.

Requirements

Qualifications

• Registered Pharmacist or Natural Science/Engineering degree.
• Strong knowledge of pharmaceutical regulations (cGMP, GDP, pharmacovigilance standards).
• Proficiency in quality management systems and Microsoft Office tools.

Experience

• 5+ years of regulatory, quality assurance, or compliance experience in the pharmaceutical industry.
• Supervisory or managerial experience in a similar environment.

Skills & Competencies

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Ability to manage multiple priorities in a fast-paced environment.
• Professional, detail-oriented, and collaborative mindset.
• Negotiation and presentation skills.

Work Conditions