Quality Manager Regulatory Affairs

IAN KABETU

R E G U L A T O R Y A N D Q U A L I T Y S M E

613-***-**** *********@*****.*** Ottawa, ON linkedin.com/in/ian-kabetu-52731814/ C A R E E R S U M M A R Y

Regulatory Affairs professional with over 21 years of experience delivering regulatory and compliance expertise across all phases of the product development lifecycle and the pre-approval, application approval and post-approval processes. Proven record of submitting comprehensive dossiers and documents, leading quality management (ISO 9001) and change initiatives, acquiring licenses, auditing regulatory processes, and complying with GMP to obtain approvals. Acquiring/managing talent, coaching/mentoring teams, continually improving/streamlining SPOs, improving operational efficiency and controlling regulatory budgets across medical devices, drugs, veterinary products, nutritional, biologics, biosimilars, health/sports supplements and food/seafood domains within the pharmaceutical, food and beverage industries. Long-term interests in applying expert regulatory knowledge to strategically facilitate product innovation while interpreting regulatory guidelines, expediting submissions/approvals, building agile teams, and accomplishing organizational objectives. E D U C A T I O N

Postgraduate Studies / Niagara College / St. Catharines, ON Sep 1998 – May 1999 Environmental Management

Bachelor of Science / University of Western Ontario / London, ON Sep 1994 – May 1998 Chemistry and Environmental Science

D O S S I E R S

• New Drug Applications,

NDA

• Biologics Licence

Applications, BLA

• New Medical Device

Applications, NMA

• New Chemical Entity, NCE

• Marketing Authorization

Applications, MAA

• Abbreviated New Drug

Applications, ANDA

• Abbreviated New Drug

Submissions, ANDS

• Abbreviated New Animal

Drug Applications, ANADA

• Drug Identification Number,

DIN

• Natural Health Products,

NHP

• Investigational New Drug,

IND

• Investigational Device

Exemption, IDE

• Investigational Testing

Authorization, ITA

• Clinical Trial Applications,

CTA

• Generally Recognized as

Safe (GRAS)

• Supplements

• Amendments

• Pesticides Regulatory

Compliance and

Registration

• Certification of Free Sale

• Health Certificates

• Food Ingredient Petitions

• CMC/GCMC

• Medical Devices

Establishment License

• Drug Establishment

License

• Narcotic License

R E G U L A T O R Y AND C O M P L I A N C E S K I L L S

• Regulatory Strategy

Development

• Regulatory Audits

• Regulatory

Documentation

• Regulatory Response

Management

• Regulatory Budget

Management

• Regulatory Governance

• Regulatory Outsourcing

• Standards Development

• Trend Analysis

• SOP Development

• Policy Development

• Agency Inspections

• QA/QC

• Stakeholder Engagement

• Product Labeling

• Product Safety Evaluation

• Site Licensing

• Change Control

• Trademark Administration

• Product Lifecycle

Management

• CAPA/RCA

• GMP

• Data Analysis

• Medical Gases GMP

Compliance

• ISO 9001

• Continuous Improvement

• KPI Management

• Contract Administration

• Vendor Management

• Project Management

• Risk and Safety

• Waste Management

• EXIM Documentation

• RFP/RFI Negotiation

• SAP/Pronto

• ERP Validation

• TQA & Supplier

Qualification

• ALR (MDEL/DEL)

K E Y A R E A S O F E X P E R T I S E

LEADERSHIP AND STRATEGIC PLANNING

• Develop regulatory and compliance strategies to submit dossiers against new product development across the PLC

• Build contingency plans and strategies through scenario planning exercises to identify and mitigate risks

• Lead regulatory affairs and quality management teams, implementing performance-driven and quality-oriented cultures to drive productivity and continuous improvement

• Spearhead the talent acquisition process to recruit, onboard, train and mentor regulatory professionals on cGMP auditing procedures

• Create agile, cohesive, and motivated teams through team building activities, open communication channels and minimal hierarchies

• Coordinate with senior managers to forecast and control regulatory affairs budgets while minimizing costs and improving the bottom line

• Identify and streamline internal processes and procedures to improve operational efficiency

• Review and approve marketing collateral to advertise and promote products, devices, and supplements

• Introduce, direct, and manage change initiatives, effectively communicating with the team to eliminate barriers to change

• Guide the organization in managing the pre-/post-marketing phases, and application approval and post-approval processes throughout the PLC

• Liaise with customers, attorneys, and consultants to facilitate a sound understanding of product development status and applicable regulatory requirements

• Review change control documents to succinctly describe changes, identify the rationale behind implementing the changes and guide the initiators on writing the change control documents

• Keep abreast of proposed changes to Health Canada’s regulatory frameworks, advising the senior management about the effects of the change

• Collaborate with overseas counterparts to create import/export and other relevant foreign registration documentation REGULATORY AFFAIRS AND COMPLIANCE

• Ensure DEL, MDEL, Controlled Drug Substances license requirements as a wholesaler/Distributor are met

• Draft, amend and file regulatory dossiers, supplements, variations, and annual reports with applicable Global Regulator Authorities, including FDA, Health Canada, EMA, SFDA, TGA, USDA, CFIA, NHP Directorate, to comply with GMP, GFI, USP Chapters, 21CFRS, ICH and VICH guidelines

• Collaborate with multifunctional teams to compile dossiers, resolve issues in regulatory submissions across pharmaceutical, biologics, biosimilars, health supplement and nutritional products

• Classify variations, and composing response packages for the regulatory authorities

• Liaise with national and international health authorities during pre-submission meetings to understand regulatory requirements for new product development (pre-clinic to marketing)

• Collaborate with the QA, R&D, and marketing teams to establish risk-based solutions to address regulatory needs

• Ensure adherence of all drafted dossiers and submission documents with national and international standards and protocols

• Coordinate with statutory authorities to audit/inspect regulatory practices and update SPOs, policies and work instructions in line with applicable frameworks

• Plan, compose and submit pre-/post-approval CMC dossiers while ensuring GCMC contribution to global regulatory strategies across a diverse project portfolio

• Generate and maintain Regulatory Strategy Documentation to coordinate responses to queries from regulatory health authorities

• Create product labelling specifications and SOPs, and coordinate with the translating agencies to translate labels while complying with domestic and international label requirements

• Facilitate post-approval compliance of the manufacturing, controls, labelling and trade dress evaluations with relevant frameworks

• Facilitate clinical trial application approvals and amendments for Phase I, II and III trials

• Collaborate with the US Patent and Trademark Office (USPTO) to administer existing and new trademarks for food products

• Interpret applicable FDA and international regulations to enable the research, development, and manufacturing of animal-based products

• Monitor and identify opportunities created by competitive product restrictions to develop new products and improve the effectiveness of existing products

• Vetted: Structure function claim substantiation, Health Claims, Nutrient Content Claims (Dietary Supplements/Foods)

QUALITY AND SAFETY MANAGEMENT

• Implement and maintain ISO 9001 QMS across the production facility and warehouse to achieve regulatory compliance

• Drive sustainability initiatives to manage licensing processes and comply with contractual obligations to achieve KPIs, improve client satisfaction and resolve complaints

• Monitor the performance of the quality management systems to establish and report opportunities for improvement

• Coordinate with the operations team to streamline internal processes and enhance product/service quality

• Define, create, and implement quality/audit parameters, analyzing audit reports, product investigations/complaints and calibration logs to maintain quality standards IAN KABETU

• Mentor, coach and train the Quality, Safety, and Risk Associates through awareness/training programs to promote a quality-driven culture

• Oversee all internal and 3rd party audits, manage CAPA/RCA responses and track effectiveness

• Generate customer TQA (Medical Devices and Pharmaceuticals)

• Supplier qualification

PROJECT, PROGRAMME AND OPERATIONS MANAGEMENT

• Coordinate with the clinical project management team to create project plans/schedules and define the project scope

• Liaise with vendors to negotiate contracts (RFIs/RFPs) and select vendors based on prescribed criteria

• Develop governance frameworks, define KPIs and the mechanisms to escalate and track issues, implement Corrective and Preventive Actions (CAPA) and manage vendor performance

• Construct outsourcing models to support strategic planning initiatives and translate strategic decisions into operational plans

• Build and deploy cost-effective working models to allocate resources and continually evaluate the Regulatory Affairs department’s workloads to improve operational efficiency

• Foster healthy relationships with critical stakeholders and customers to deliver regulatory expertise and improve stakeholder satisfaction/experience

• Resolve issues on projects assigned to cross-functional teams as the single point of contact while representing GCMC

• Manage and complete regulatory projects within prescribed timelines and forecasted budgets

• Coordinate with critical internal stakeholders to generate domestic and international government contracts

• Develop regulatory action plans and review drug filing information to comply with regulations, policies and relevant guidelines while filing electronic Drug Registration and Listings

• Deliver regulatory expertise to project teams, recommending strategies to receive the earliest possible approvals for submissions

• Collaborate with the R&D department on new product development projects, providing regulatory expertise throughout the PLC

E M P L O Y M E N T H I S T O R Y

DIRECTOR, QUALITY SYSTEMS QUALITY CONTROL Sep 2019 – Present Ontario Medical Supply Inc / Ottawa, ON

Core Responsibilities:

• Lead a team of four direct reports to develop, execute, maintain, and drive continuous improvement (Quality Management System/ISO 9001:2015) across all applicable sites

• Ensure regulatory compliance for the distribution of: Pharmaceutical Drugs, Medical Devices & Controlled Drug Substances at all applicable sites

• Ensure warehouses adhere to Health Canada GMP regulatory standards (Storage and distribution: Drugs, Medical Devices & Controlled Drug Substance) -Taking a risk-based approach

• Inspection readiness/Ensure an effective self-inspection/audit program with a remediation and metrics management program

• Establish and maintain GMP related documents including SOPs, WIs as well as records management

• Establish Quality Agreements with clients; Participate in Client meetings (Monthly/Quarterly business reviews)

• GMP regulatory compliance (At all sites):

o Recall, Quarantine, Return Disposition, In Bound Release, Pest Control, Sanitation, Vendor Qualification, Record Retention, Calibration, Preventive Maintenance, Effective CAPA Plans, Customer Complaints, Product Complaints, Recalls, Change Controls, Shipping Validation/Qualification Studies, Temperature Deviations (Excursions), Internal Audits (Self Inspection), GMP Training REGULATORY SME (CONSULTANT) Sep 2019 – Aug 2020

UTI Limited Partnership (Impact) / Impact Clinical Trial Accelerator / University of Calgary / Calgary, AB Core Responsibilities:

• Spearheaded the IMPACT Regulatory program and ventures while supervising the IMPACT team and Regulatory Assistants on the following (Medical Devices Class II, III, IV): o Managing relevant and appropriate regulatory documentation for each clinical trial o Directing the collection and maintenance of regulatory documents and master files o Documenting and reporting safety-related and adverse events during the trials o Adhering to appropriate quality management, assurance, and control (QM/QA/QC) processes o Researching for updates on domestic and international guidelines and regulatory standards while summarising, recommending, and streamlining internal processes IAN KABETU

REGULATORY AFFAIRS MANAGER US Oct 2018 – May 2019

Chanelle Group / Ireland

Core Responsibilities:

• Compiled and submitted ANADA regulatory dossiers, ensuring compliance with GFIs, USP Chapters, CFRs, ICH and VICH guidelines for the Veterinary and Medicinal products ASSOCIATE DIRECTOR OF REGULATORY OUTSOURCING AND VENDOR MANAGEMENT Oct 2016 – Sep 2018 Merck KGaA / Germany

Core Responsibilities:

• Selected vendors after negotiating contracts (RFIs/RFPs) and managed vendor performance by implementing Governance frameworks and developing KPIs

MANAGER, REGULATORY AFFAIRS SUBMISSIONS Oct 2015 – Sep 2016 PharmaLex / Germany

Core Responsibilities:

• Submission Compilation and CMC Authoring – Global pharmaceutical dossiers MANAGER, REGULATORY AFFAIRS SUBMISSIONS Aug 2012 – Aug 2015 LifeScan Scotland Ltd / Scotland

Core Responsibilities:

• Led a team of six regulatory professionals to develop regulatory strategies and implement plans to submit approval documents for new medical devices and IVD products (Global) GCMC STRATEGIST/AUTHOR (CONTRACT) Aug 2011 – Aug 2012 Pfizer / Canada

Core Responsibilities:

• GCMC contribution to the global regulatory strategies on a diverse project portfolio to generate and maintain Regulatory Strategy Documentation and submit regulatory dossiers for consumer care/OTC nutritional and pharmaceutical products

REGULATORY AFFAIRS AND QUALITY MANAGER (CONTRACT) Sep 2010 – Aug 2011 Healthy Body Services Inc / Canada

Core Responsibilities:

• Planned, prepared, and submitted regulatory dossiers, developed product labelling specifications, and ensured conformance of products with domestic and international regulatory frameworks and quality requirements for Sport Supplements and Nutritional products

SENIOR REGULATORY AFFAIRS ASSOCIATE (CONTRACT) Apr 2010 – Sep 2010 Cangene / Canada

Core Responsibilities:

• Prepared and submitted regulatory documents, supplements, amendments, variations, and annual reports for biological drugs across Canada, the USA, Europe, Australia, New Zealand, the Middle East, and other international markets

INTERNATIONAL REGULATORY AFFAIRS PROJECT MANAGER Nov 2004 – Oct 2009 Perrigo / USA

Core Responsibilities:

• Prepared and submitted regulatory dossiers, developed product labelling specifications, Structured Function Claim Substantiation (DSHEA/NHP), Marketing Claims (Nutrient Content Claims) and assured the conformance of the consumer care/OTC nutritional and pharmaceutical products with US and Canadian regulatory frameworks REGULATORY AFFAIRS COORDINATOR Mar 2003 – Oct 2004 King & Prince Seafood Corp. / USA

Core Responsibilities:

• Prepared and submitted food ingredient petitions, export/import documentation, ingredient statements and nutritional panels for food labels, maintained facility registration and developed quality assurance programs for adhering to GMP guidelines

REGULATORY AFFAIRS SPECIALIST May 2000 – Mar 2003

Nitta Casings Inc. / USA

Core Responsibilities:

• Prepared export/import and foreign country registration documentation according to the country’s specific requirements

• Developed labelling specifications, recommending quality policies to senior managers, and interpreting applicable FDA and international regulations regarding the manufacture of animal-based food products

• Created and implemented HACCP/GMP Programs across the production facility

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