Regulatory Enforcement Coordinator

Job Purpose / Objective

Responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.

Key Responsibilities / Accountabilities

• Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications.
• Provide expert regulatory input to in licensing evaluations and due diligence activities.
• Keep up-to-date with changes in regulatory legislation and guideline
• Write comprehensible, user -friendly, clear product information leaflets and labels.
• Liaise and negotiate with regulatory authorities
• Develop and establish policies and standards that convey the best practices in the company
• Review and report overall quality status to the management team
• Assembles a regulatory file/dossier: coordinates acquisition of all applicable data; assessed data; drafts and submits the regulatory file.
• Monitors product files in the developmental phase: updates data; reconciles requests from authorities Based on scientific and ethical constraints; makes amendments/changes and submits them to authorities
• Conducts regulatory monitoring of approved products: Assists and supports in-house teams; maintains files current; ensures regulatory compliance; evaluates the effects of an amendment/change; takes appropriate regulatory actions.
• Provides counselling to internal and external clients with regulatory issues: Ensures regulatory monitoring; formulates a regulatory opinion; supports employees and the management team; represents the company; conveys information about regulatory matters and their application
• Formulates an organized contingency plan based on the project’s critical factors and a risk-mitigation plan
• Preparation, Submission, and Follow-up of a Regulatory File
• Revises and approves the information in the product
• Consistently meets assigned deadlines to ensure client satisfaction.
• Perform other applicable task and duties assigned within the realm of his/her knowledge, skills and abilities.

Education/ Professional Qualification

• Bachelor’s Degree in Law or related field.

Experience

• Preferably four  (4) years’ relevant experience.

Professional Licensing / Certification / Training

• N/A