Your Responsibilities
Job Purpose
To compile and submit registration dossiers in accordance with the country specific requirements to relevant Regulatory Authorities in East Africa.
Dossier Maintenance Submission of post registration variations in line with country specific regulatory requirements
Submission of updated product Package insert or labeling updates in line with country specific requirements and in line with the internal GSK requirements.
To maintain the relevant Global and local Regulatory and compliance databases
To align regulatory product registration submission strategy to commercial product strategy
Manage and develop strategies that overcome regulatory challenges for new product registrations and line extensions
Review of promotional materials to ensure adherence to country specific requirements
Regulatory ExecutiveBusiness growth through new products registrations and maintaining the registrations (license renewals/license validity and lifecycle management) on an ongoing basis in the assigned country/region, thus ensuring continuity of supply and regulatory conformance to all applicable laws and guidelines.To ensure that any other applicable licenses, e.g. Wholesale licenses and Medical representative permits are issued by the regulators.To ensure QMS objectives for the assigned country/region are met.
ScopeBusiness development
Expand geographical niche to deliver growth by New Product Registration Business
Ensure registration licenses are maintained (license renewals/license validity) on an ongoing basis in the assigned country or region.
Ensuring continuity of Product Supply by submitting and following up on lifecycle management changes (CMC and labeling changes) with the regulatory authority.
To ensure that trading licenses, Wholesale licenses and Medical representative permits are issued by the regulators
Guidance and technical advice to Commercial Teams (Demand & Supply, Tenders and Pharma Marketing).
Regulatory Compliance
Maintenance of all regulatory databases as per applicable SOPs and Guidelines
Ensure that the OPAL database is updated on a regular basis.
Ensure timely submission of Registration dossiers for registration/variations and ensure that the licenses are maintained on an ongoing basis.
Support the artwork control process in Agile or any other GSK system to ensure changes and approval are done in time to avoid product stock out or delays in supplies.
Product lead on all GSK Pharma and Vaccine portfolios in the assigned country TANZANIAMedical Governance
To ensure that any Regulatory Compliance issues from the assigned country are promptly notified to the line manager and the Medical Governance Committee (MGC)
Essential Job Responsibilities
Evaluation, compilation and submission of Registration Application dossiers to Eastern African Regulatory Authorities, which is an accurate and ethical presentation in accordance with established format.
Maintenance or registration dossiers including submission of renewals in the relevant markets
Submission of labeling updates in line with the GSK timelines and requirements and country specific requirements
Evaluation of artwork and initiation of artwork changes where relevant
Review of promotional material
Liaising with the regulatory Authorities in Eastern Africa.
Review of promotional material in accordance with GSK Promotional and Marketing Code
As Regulatory Executive
Ensure timely submission of Registration dossier for registration on an ongoing basis for the assigned country, Business growth through submission and registration of new chemical entities (NCE) / New Products and established products as part of the PREP Project.
To prepare regulatory dossiers and letters, for new products within the assigned country or region (or for any other country in East Africa as and when required) which involves
Requests to Central for Dossiers, CD/ Electronic, samples, COPP, CoA, GMP certificates
Preparation
Review
Submission,
Follow up
Liaise with Regulatory Authorities on matters relating to Regulatory approvals for GSK Products.
Response to Queries (RTQ’s)
requests for additional information
Post Approval commitments (where applicable)
License Retention and renewal follow ups
Submit Variations
Maintaining and review of regulatory databases with registered product information on local systems and repository areas for CPP, GMPs as per applicable SOPs and Guidelines e.g. OPAL, Shared Regulatory Databases, PRION, ISIS, OPAL Vaccines, RABIS.
Ensure registrations are maintained (license renewals/license validity) on an ongoing basis in East Africa. Maintain product registrations by ensuring re-registrations/renewals are done on time and notifications to changes on the registered details are also done in a timely manner.
Gather Regulatory Intelligence Providing intelligence to local operating company stakeholders and central team on changes in regulatory environment in the region. Update ISIS and any future replacement.
Submission of marketing authorisation transfers/Acquisitions
To interact with Regulatory Authorities and ensure development of close and effective relationships that is of benefit to the company.
Negotiate with Regulatory Authorities on issues such as labelling, advertisement approvals and product complaints.
Supply Chain continuity, validity of existing licenses/marketing authorisations
Submission of variations namely clinical extensions, source changes, pack amendments, shelf –life extensions, formulation and finished products specification changes.
Works with HOD to ensure that SOP’s that impact on QMS are reviewed, whilst maintaining visibility on all steps of the changes.Support the QMS departmental ChampionPlay a role in risk mitigation and meeting GSK standards of operationEnsure that Level 1 and Level 2 audits within the Country are carried outWork with QMS team/other departmental members to ensure risks are identified and managed
Scheduled training for teams on L1 audits and provide them support during audits
Ensure that CAPAs are set and those accountable follow through with implementation
Schedule and confirm compliance with QMS meeting actions
Medical Governance Team Member
Support Medical Governance By Meeting Company AE Reporting Requirements
Notifications of Regulatory Compliance issues to MGC.
Complexity
Challenging the constraints of Regulatory Authorities on regulatory issues
Handle communication with Regulatory Authorities on product recall situations with a view of minimizing negative impact for GSK
Devise efficient filing strategies for a fast submission and approval turnaround time
High risk compliance issues involved in the role.
Combining 4 different roles and still ensure achievement of department’s as well as individual’s objectives.
Focussing on assigned Portfolios and Markets while maintaining regulatory visibility on other markets.
Interaction with many internal and external players.
Interaction with cross functional teams e.g. in QMS Team.
This position is governed by GSK SOPs, GQPs and Government Regulatory Guidelines, Legislations and Proclamations.
Requires constant awareness of regulatory environment.
Dynamic environment within which Regulators operate pose a challenge in how or who will tackle issues.
Country Regulatory lead for As assigned by the Line managerWorking closely with the Regulatory Executives/Manager to achieve the market’s Regulatory Objectives.
Why You?
A University graduate with Bachelor of Pharmacy or Science based degree or equivalent
Work experience of 2-5 years in pharmaceutical regulatory environment
Good interpersonal skills, high integrity and ability to engage in ethical conversations are a pre-requisite
Excellent communication skills
Knowledge
Knowledge and experience of Regulatory Affairs in markets in Eastern Africa
Independent Thinking
Lobby and network with Regulatory Authorities for fast track approval of GSK products.
Provide regulatory support/training to stakeholders as appropriate
Pressure
Ability to work well under pressure and still maintain sound balance in decision making.
Ability to meet the deadlines for the strategic and tactical plans.
A minimum of a Life science degree from a reputable university within the EA region.
Diverse regulatory requirements in the region require vast experience and technical knowledge to ensure full compliance. Good working knowledge of regulations, current industry practices, and strong experience with interpretation and application. Experience in domestic environment with international regulatory environments with the ability to seek out, understand and apply regulatory guidance from internal and external sources, and maintain focus on compliance as the highest priority
Managing complaints and reporting requires knowledge and experience in pharmacology and phamacovigilance.
Excellent written and verbal communication, presentation, and facilitation skills
Communication and Working with Multifunction teams both within and without GSK Kenya.
Participate in crisis management
Two to three years minimum experience in pharmaceutical regulatory governance
Training on relevant GSK policies and SOP’s
Good communication and presentation skills
Good team player and have demonstrated ability to motivate teams.
Good understanding of the Regulatory environment
Ability to make evaluative judgments.
Ability to communicate and interact competently and professionally at all levels within a broad, complex environment.
Skill in the use of computer technical, and database applications.
Good working computer knowledge.
Daily communication with Regulators and Internal Customers.
Good understanding of Regulatory and QMS business processes
Ability to harness the commitment & contribution of team members outside of department
Strong analytical skills
Good collaboration and negotiation skills
