Lucy Mwangi

Regulatory Submissions

• Reviewed and submitted CTD dossiers, facilitating timely product approvals.
• Managed submissions for post-approval amendments, product renewals, and retention processes.
• Supported submissions through the EAC and ZAZIBONA Joint Assessment Routes

Regulatory Compliance

• Spearhead regulatory compliance strategies for pharmaceutical products, ensuring adherence to complex regulatory requirements across multiple jurisdictions (Kenya, Tanzania, Uganda, Rwanda, Zambia, Botswana, Zimbabwe, Namibia,Madagascar and Mauritius)

Regulatory Intelligence

• Monitored evolving regulations, updating internal teams and aligning strategies with the latest requirements.

Pharmacovigilance

• Post-marketing surveillance and ensure compliance

Medication Dispensing

• Dispense prescribed medications and provide information to healthcare providers and patients about drug usage, dosages, and side effects.
• Ensure accuracy in filling prescriptions, verifying the correct dosage, and reviewing for potential interactions or contraindications.

Patient Care

• Collaborate with healthcare teams to create individualized treatment plans for patients, adjusting medication regimens based on the patient’s clinical condition.
• Monitor patient responses to treatments and make recommendations for adjustments to improve efficacy and minimize side effects.

Clinical Support

• Participate in rounds and multidisciplinary meetings to discuss patient care.

Patient Education

• Counsel patients and their families on the proper use of medications, potential side effects, and the importance of adherence to prescribed treatment.
  
  

• Under supervision, compound medications such as creams, ointments, and liquid mixtures, according to prescriptions and standard operating procedures.
• Verify prescriptions for accuracy and ensure proper medication labeling and dosage instructions.
• Educate patients on proper medication use, side effects, and potential interactions.
• Manage and maintain pharmaceutical stock levels, ensuring availability of necessary medications and compliance with expiration dates.
• Participate in ongoing research initiatives to improve pharmaceutical care practices.
• Maintain thorough documentation of medication orders, dispensing records, and any clinical interventions.

• Assist in the quality control (QC) and quality assurance (QA) processes by monitoring the production line for compliance with Good Manufacturing Practices (GMP).
• Help in the testing of raw materials, in-process materials, and finished products to ensure they meet specified quality standards.
• Ensure compliance with Standard Operating Procedures (SOPs)
• Participate in the calibration and validation of production and laboratory equipment, ensuring that they function according to specifications.
• Participate in training sessions to develop a thorough understanding of GMP, QA/QC procedures, and regulatory requirements.