Regulatory Officer (Registered Pharmacist)

JOB SUMMARY

Responsible for the preparation and submission of documents that support the registration of products and licenses, inventory control, handling, preparation and documentation of incoming and outgoing stock deliveries. Responsible for evaluating the Company’s regulatory procedures and processes, providing support in delivering adherence stakeholders’ requirements – local and international regulation customers, consumers, etc.

Support the function of the Department to: plan, implement and monitor regulatory procedures and activities (Company policies and Quality Management System – QMS) coordinate the review process for documents taking corrective actions when necessary. Enabling the quality culture at the facility DUTIES & RESPONSIBILITIES Adhere to regulatory practices in keeping with applicable regulatory and Company requirements.

Adhere to the Company’s quality & customer service standards and procedures. Assure sensitivity to confidential data is maintained. Demonstrate sufficient and required knowledge/awareness of Company policies and procedures governing the Company’s regulatory functions. Collate and compile documents prepared for submission to Health Authorities/external stakeholders for drug registration, variations and permit application.

Efficiently maintains accurate and timely reports, assuring effective recordkeeping. Maintain records and pharmacy files that support the Pharmacist(s)’s accountabilities. Prepare documents to apply for all necessary approvals and marketing permits from applicable regulators, and track, obtain and renew any required permits and licenses.

Track, monitor and prepare reports related to specific Regulatory KPI’s within the facility. Ensure the application of and adherence to established HSE measures and procedures to ensure the well-being of themselves and employees. Execute Pharmacovigilance and Regulatory-related training activities. Maintain, renew, and update facility licenses, GDP certificates, narcotics/controlled substance permits, and import/export permits.

Manage quarantine protocols for damaged, suspected counterfeit, recalled, or returned medicinal. Participate in weekly/planned stock count, dispatch and reconciliation of Antibiotics, Controlled Drugs & Narcotics. Participate in the documentation of regulatory policies and procedures for continuing improvement of the regulatory operations.

Implement and maintain regulatory database(s) for the effective and efficient management of critical information Participate and lead root cause analyses of regulatory breaches through collaboration with cross- functional teams. Participate in the implementation and maintenance of the Company’s quality culture (e.g. coaching, active communication with staff as it relates to regulations, etc.)

Participate in projects aimed at continuous improvement of the operations at the Distribution Center. Perform final release checks for cold chain, ensuring compliance with import permits, and packaging specifications. Provide technical instructions to warehouse and supply chain management regarding product compatibility, specialized storage requirements, and hazard handling.

Provide administrative support to the Regulatory Manager and Company stakeholders in a timely manner, executing responsibilities accurately. Report any hazards, which are identified to direct Supervisor/Manager and the Company’s Safety/HSE Representative. Serve as the primary liaison for health authorities and regulatory bodies regarding distribution center operations, licenses, and inspections.

Supervise the compliant handling, storage, and reconciliation of controlled drugs, psychotropic substances, and precursor chemicals. Support continuous improvement through reporting non-conformance, customer complaints & process improvements to immediate Manager. Support the Regulatory Manager in the management of all post approval activities e.

g. Pharmacovigilance, notifications etc. Track changes in local and international pharmaceutical legislation, GDP, and supply chain rules, updating internal policies accordingly. Perform other quality/regulatory-relevant duty assigned from time to time, to enhance the Company’s operations. PERFORMANCE CRITERIA: This job is satisfactorily performed when: Administrative support is given to the Junior and Senior Pharmacist in the timely and accurate execution of their responsibilities Reports are accurate and timely Sensitivity to confidential data is maintained.

There is efficiency in record keeping. There is adherence to Regulatory practices There is sufficient knowledge of Company’s policies and procedures A satisfactory working relationship is encouraged and developed with all employees as espoused and guided by Group and Company Values. OTHER DUTIES Please note this Job Description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required by the employee for this job.

Duties, responsibilities and activities may be modified at any time with or without notice. AUTHORITY Contact and liaise with Regulatory Manager when matters need escalation Report breeches to the leadership team Monitor adherence of regulatory protocols QUALIFICATIONS Education: Bachelor of Pharmacy (B. Pharm) or Doctor of Pharmacy (Pharm.

D) degree from an accredited institution. Licensure: Active and unrestricted Registration/License as a Pharmacist with the relevant national Pharmacy Board or Council. Experience: 2–5 years of experience in regulatory affairs, pharmaceutical quality assurance, or warehouse distribution compliance. KNOWLEDGE, SKILLS AND ABILITIES Good interpersonal and communication skills Possess knowledge in applicable regulatory matters affecting (might affect) the business.

Required Skills

and Specialized Techniques Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction. Effective time management skills Ability to communicate effectively Integrity — Job requires being honest and ethical. Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations.

Attention to Detail — Job requires being careful about detail and thorough in completing work tasks. Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks. Initiative — Job requires a willingness to take on responsibilities and challenges.

Cooperation/Team oriented — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude. Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations. Ownership – own the process and its results; does not shirk personal responsibility Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace; being solution oriented.

Independence — Job requires working in a team setting for doing things, guiding oneself with some supervision, and collaborating with direct report to get things done. Self-Control/Emotional Intelligence — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.

Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems. Customer Focused – Job requires meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with external stakeholders and gains their trust and respect.

Committed to personal growth and development Results Oriented/Persistence

• Can be counted on to consistently produce results and even exceed goals successfully; plans and sets priorities well; solution oriented Special Conditions Associated with the Job Ability to work flexible schedule Must be physically able to work in a warehouse setting Attention to Detail — Job requires being careful about detail and thorough in completing work tasks. Must be able to function independently and handle a variety of responsibilities under pressure. Dependability in being reliable, responsible, and dependable, and fulfilling obligations. COMPETENCIES Excellent communicator Analytical thinker Leadership Team oriented Performance driven/result oriented Meticulous in execution Customer Focused WORKING RELATIONSHIPS External: Suppliers, Regulatory Agency, Customers Internal: Quality Manager, Regulatory Manager, Process Owners, Quality Officer, All warehouse staff WORKING CONDITIONS This role is full time between the hours of 8 am – 5 pm. You will be expected to work beyond standard operating hours as the need arises and your co-operation is anticipated. Please note this role will require over-time based on business needs. HEALTH AND SAFETY All employees must adhere to the Health and Safety policies of Facey Commodity Company Limited and especially practice safe and responsible drinking habits to ensure sobriety while representing the company at events and while attending company functions.