SUSAN WANJIRU NDUNGÚ
Regulatory Affairs Specialist
Nairobi,Nairobi
Summary
Licensed pharmacist with Pharmacy and Poisons Board, Nairobi, Kenya. Experienced professional equipped with skills in:
- A deep understanding of regulatory requirements and industry standards in the region. Experience in preparing and submitting regulatory filings, such as applications for product approvals, registrations, or licenses.
- Familiar with regulatory agencies in the region and have experience communicating with them to ensure compliance with regulations.
- Experience working on cross-functional teams, collaborating with colleagues from governance, finance, quality control, and other departments to ensure regulatory requirements are met.
- Participated in audits, inspections, and compliance reviews, identifying areas of non-compliance and developing corrective and preventive actions to ensure ongoing compliance.
- A strong attention to detail and an ability to work in a fast-paced, highly evolving and highly regulated environment.
- Developed skills in project management, communication, and problem-solving, and committed to ensuring that the organization complies with regulatory requirements.
- Experience with developing risk management frameworks that identifies potential regulatory risks and provides a plan for managing risks that can impact business performance.
- Built relationships with regulators to keep informed of regulatory changes, build credibility and also create opportunities for collaboration.
Overview
7
7
years of professional experience
9
9
years of post-secondary education
Work History
Company Pharmacist
Roche
Nairobi
2018.02 - 2022.06
- In accordance with requirements of Cap 244 - Pharmacy and Poisons Act, was appointed as Company Pharmacist. Responsibilities included:
- - Primary person of contact to Kenya Pharmacy and Poisons board on behalf of Roche Kenya Ltd.
- - Issued with import license that enabled importation of company's products.
- - Company representative in relevant external stakeholder engagements including: industry associations and global regulatory engagements.
Regulatory Affairs Specialist
Roche Diabetes Division
Nairobi
2018.01 - 2022.06
- Prepared and submitted regulatory file applications and supporting documentation.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Consolidated global information relevant to Roche Diabetes products and monitored global submissions and approvals status.
- Received, researched and resolved consumer inquiries.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Maintained and archived regulatory paperwork.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
Regulatory Affairs Specialist
Roche
Nairobi
2016.01 - 2022.06
- Oversaw product portfolio of more than one hundred and twenty products (120) in following countries within Kenya sub-region: Kenya, Uganda, Tanzania and Rwanda. Responsibilities included the following:
- Preparing and maintaining document inventory for core dossier preparation. Submission of regulatory file applications and supporting documentation in line with company's strategy.
- Interpreting new and revised regulatory guidelines. Compiled and communicated impact assessed with relevant stakeholders through corporate policies and procedures.
- Consolidating global information relevant to the companies therapeutic area strategies and monitoring global submissions and approval status for local pipeline alignment.
- Implementing regulatory guidance procedures for maintenance of product life cycle. This included: timely submission of post- approval changes, renewal and retentions of licenses
- Working with governance committees to make and evaluate plans especially in relation to therapeutic area strategies.
- Received, researched and reported consumer inquiries in relation to product complaints to relevant regulatory bodies. Consumer inquiries included: counterfeit concerns, storage queries and adverse effects.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Assisted with regulatory product compliance initiatives such as audits, risk assessments and regulatory intelligence.
- Formatted, created and reviewed labeling and packaging data to assess and ensure compliance with regulatory body regulations in different countries in my portfolio.
- Recommended improvements to processes. Achieved this by fostering engagements of other cross-functional teams in the company with regulatory governing bodies in the region. This gave the medical affairs teams a platform to engage authorities and present clinical data in support of filed applications.
- Maintained and archived regulatory paperwork in accordance with company policies.
- Coordinated recall and market withdrawal activities as necessary.
- Wrote and reviewed standard operating procedures, work instructions or policies.
- Developed and tracked quality metrics that included: submission timelines, responses to queries from governing regulatory bodies.
- Prioritized project-related tasks to efficiently complete essential tasks in line with company's strategies.
- Training and education. By providing training and education to employees to ensure that everyone in the organization understood regulatory requirements and how to comply with them. Achieved this by developing training programs and materials to educate employees on key regulatory issues and requirements.
Product Development Pharmacist
Universal Corporation Limited
Nairobi
2015.06 - 2016.05
- Performed product preformulation studies, design optimization, product re-formulation, validation and equipment qualification
- Ensured adherence of GMP in production to ensure quality in products was enforced and prepared monthly reports on the status of products under development
- Worked effectively in a fast-paced environment.
- Organized and detail-oriented with a strong work ethic.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Cultivated interpersonal skills by building positive relationships with others.
- Skilled at working independently and collaboratively in a team environment.
- Strengthened communication skills through regular interactions with others.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Gained strong leadership skills by managing projects from start to finish.
Education
Master of Science - General Health Science
2010.04 - 2012.04
Bachelor of Pharmacy - Pharmacy
2006.01 - 2009.01
Kenya Certificate of Secondary Education - High School
2000.01 - 2003.11
Skills
Regulatory Management
Quality AssuranceBusiness Intelligence and Strategy
Quality Management SystemsOperational AnalysisOral and Written Communication
Pharmacovigilance FrameworksGood Documentation PracticeRisk Management and Audit Support
Project Management
Business Strategy
Company policy compliance
Documentation skills
Attention to detail
Adaptability
Accomplishments
- As a Roche employee, I continued my passion on giving back to the community
- In line with this, I was selected as a committee member of both Children's walk and Children Education (Aiducation) partnership.
- During my studies, I volunteered for Phelophepa Train, a train that operates as a mobile healthcare hospital offering medical services to impoverished rural areas of South Africa. I worked together with other health professionals on the on-board clinic to provide primary health care to the local community
- In 2015, I was selected together with other twenty pharmacist interns to take part in Industrial Training conducted at the University of Nairobi
- The training was organized by Federation of East African Pharmaceutical Manufacturers (FEAPM), GIZ and UNIDO
- The training was specifically for pharmacists' interns that had an interest in the pharmaceutical industry
- Following completion of my undergraduate studies, I enrolled for a postgraduate degree (MSc) which entailed the synthesis of Cyclo (D-Phe-2Cl-Pro) and Cyclo (Phe-4F-Pro) relating to their biological activity as antitumor, antimicrobial and hematological agents
- The research gave me useful research experience and analytical thinking skills
- During the 4th Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA IV) in Zimbabwe, I made a presentation that highlighted the impact of the Eastern African Committee (EAC) Joint Assessment Procedure and the ZAZIBONA collaborative procedure on regulatory assessments for new product launches.
TRAINING
RESEARCH
PRESENTATIONS
Timeline
Company Pharmacist - Roche
2018.02 - 2022.06
Regulatory Affairs Specialist - Roche Diabetes Division
2018.01 - 2022.06
Regulatory Affairs Specialist - Roche
2016.01 - 2022.06
Product Development Pharmacist - Universal Corporation Limited
2015.06 - 2016.05
Nelson Mandela Metropolitan University - Master of Science, General Health Science
2010.04 - 2012.04
Nelson Mandela Metropolitan University - Bachelor of Pharmacy, Pharmacy
2006.01 - 2009.01
St Brigid's Girls Kiminini - Kenya Certificate of Secondary Education, High School
2000.01 - 2003.11