Enforcement Officer

3 days ago

Riyadh, Ar Riyāḑ, Saudi Arabia Dr. Sulaiman AL Habib Medical Group Full time
Roles and responsibilities

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.
Desired candidate profile

Education/ Professional Qualification

Bachelor's Degree in Law or related field.
Experience

Preferably four (4) years' relevant experience.
Regulatory Compliance Management
Monitor Regulations: Stay up-to-date with local, state, federal, and international regulations that apply to the organization's industry and operations. Monitor changes to laws and regulations that may impact compliance requirements.
Assess Compliance Risks: Identify areas of the business that may pose risks of non-compliance with regulatory requirements. Conduct assessments and audits to ensure adherence to regulatory frameworks.
Implement Compliance Programs: Work with relevant departments to implement regulatory compliance programs and ensure that organizational practices align with the requirements of governing bodies.
Coordination of Enforcement Actions
Handle Enforcement Notices: Respond to regulatory enforcement notices and violations. This may include investigating incidents of non-compliance and preparing necessary documentation or reports for authorities.
Work with Regulators: Liaise with regulatory agencies and enforcement bodies to facilitate the coordination of compliance-related activities, inspections, or audits. Communicate findings or issues related to enforcement matters.
Develop Corrective Action Plans: Develop and oversee corrective action plans for addressing violations or areas of non-compliance, ensuring that steps are taken to resolve issues within specified timelines.

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