Sr Manager, Regulatory Affairs and Deputy Responsible Pharmacist, South Africa

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Job Description

Regulatory Affairs Senior Manager and Deputy Responsible Pharmacist South Africa

Scope

Act as Senior Regulatory Affairs Manager and the Deputy Responsible Pharmacist for Gilead Sciences South Africa. To act as the Local Qualified Person responsible for Pharmacovigilance (QPPV) in South Africa.

Specific Responsibilities

Regulatory Affairs

• Act as the deputy Responsible Pharmacist (RP) of Gilead Sciences SA and to ensure that all relevant actions are in line the South Africa Pharmacy Act and the Medicines and Related Substances Act 101 of 1965 as amended.
• Ensure that Gilead Sciences SA is compliant with all matters pertaining to registration and licensing with SAHPRA as a HCR as applicable in terms of section 22C (1) (b) of the Medicines and Related Substances Act 101 of 1965.
• To ensure that the premises and all licenses are maintained as per the South African Pharmacy Act.
• Manage the regulatory portfolio throughout the lifecycle of the product.
• Drive local registrations based on regulatory requirements product knowledge and company strategy.
• Interact with national authorities regarding regulatory issues regarding Gileads licenses.
• Liaise with International Regulatory Affairs regarding the preparation of any submissions relating to Gileads products (including clinical trials NCEs variations and line extensions) both for licenses held by Gilead and those licenses in South Africa held by Distributor Partners.
• Manage the submission and outcome of all regulatory submissions to national authority to ensure final approval and implementation of all changes in a timely and proactive manner.
• Liaise with Patient Safety and International Regulatory Affairs regarding submission of PSURs RMPs and relevant notifications.
• Submit review and maintain all artwork in line with the Gilead internal processes.
• Provision of accurate English translations of all agency correspondence and labelling for Gileads products in South Africa as necessary.
• Liaise with relevant cross-functional teams regarding introduction of packaging for South Africa
• Represent the Regulatory Function at internal and external meetings.
• Establishment of good working relationships with national authorities.
• Establishing good working relationships with all internal and external partners.
• Provision of strategic regulatory advice regarding national registration requirements to senior management and International Regulatory Affairs.
• Communicate any change to local legislation as per the internal Gilead processes.
• Comment on draft regulatory guidelines via the local Trade Associations
• Actively participate in relevant industry working groups
• Support cross-functional teams during the launch of any new product
• Having oversight of the provision of scientific information about Gileads medicinal products in the territory.
• Ensuring in conjunction with General Manager and Medical Affairs that Sales Representatives in country (both Gilead and commercial partners) transmit any new information to Medical Affairs given to them by health care professionals about the use of Gileads products that would add to the body of knowledge about that product.
• Provision of guidance and assistance to Marketing (both Gilead and commercial partners) during preparation of promotional material.
• Review and approval of artwork changes and promotional material in accordance with the Gilead internal promotional guidelines national legislation and Codes of Practice.
• Ensure provision of updated approved product labelling to relevant personnel for all products.
• To ensure that all local promotional activities are reviewed and approved as per the South African Marketing Code
• An active member of the South African office and support cross-functional requests (as applicable)
• Perform all required reporting obligations in a timely manner.
• Support the individuals and teams in other functions in the performance of their duties for the South African country office as required.
• Provide Regulatory Affairs input to crisis and incident management and business continuity planning and events as required.

Quality Affairs

• To maintain and improve the local Quality Management System (QMS) on a continuous basis.
• To support the maintenance of the local Site Master File (SMF) and update/submit to SAHPRA as required.
• Maintain all relevant SOPs and improve where required.
• Ensure continuous audit and inspection readiness. To manage and support any internal or external audits in line with the local Gilead procedures.
• Release product batches according to internal procedures.
• Support the management of product complaints product withdrawals and product recalls.
• Support samples management which includes retention samples and post-importation sampling.
• Support the management of all third-party vendor quality agreements.
• Responsible for the correct destruction of expired and rejected goods.
• To maintain GMP and QA at all times
• Management of Change Controls deviations and CAPA process at Gilead Sciences SA in line with internal Gilead processes.
• To ensure that all other functions related to manufacturing/distribution of products are at all times conducted according to procedures and adheres to the requirements of SAHPRA.

Pharmacovigilance

• Acts as the local Qualified Person Responsible for Pharmacovigilance (QPPV) and maintains oversight of all local pharmacovigilance activities for Gilead Sciences South Africa in line with SAHPRAs requirements.
• To establish and operate the local Pharmacovigilance system for medicines registered in South Africa.
• Develop and maintain a local PSMF that describes the local pharmacovigilance system for medicines registered in South Africa.
• Develop and maintain product-specific risk management systems in collaboration with international Patient Safety.
• Responsible for ensuring the appropriate development and revision of local RMPs PSURs and country specific annexes in collaboration with Global Patient Safety Teams.
• Responsible for training for Affiliate staff on safety reporting procedures including the timely reporting of safety information to Patient Safety (PS)/ Affiliate Head of Patient Safety e.g. new hire training sales and solicited programs training and ensuring all training is documented.
• Provide oversight & leadership of the local risk minimisation activities and materials as applicable.
• Responsible for all GVP inspections and audits as appropriate.
• Maintaining knowledge of global PDs as they pertain to Affiliate(s) and ensures that local PDs including a Business Continuity Plan (BCP) are in place for specific local processes that are not covered by a global PD.
• Ensuring an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented.
• Maintain local expert knowledge and update the relevant procedural documents when and where requires. Communicate any updates to local legislation to global Patient Safety as per internal requirements.
• Ensure that local business partners consider the impact of local Safety and have the relevant oversight into these activities (PSP Market research Digital media etc.)

Specific requirements:

• degree
• Registered as Pharmacist with the South African Pharmacy Council
• Extensive experience within Regulatory Affairs

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.