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  • Posted: Jan 20, 2021
    Deadline: Not specified
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    The way we see it, the impossible is not impossible. Its simply what hasnt been achieved yet. For more than 30 years, weve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. Its evident in our missi...
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    Manager, Regulatory Affairs

    We have an exciting opportunity for aRegulatory Affairs Manager and Deputy Responsible Pharmacist in the South African Affiliate. This role will be based in Johannesburg, South Africa.
    The RA Manager is responsible for ensuring that Gilead´s medicinal products in his/her responsibility can be developed, authorized and maintained on the market, in compliance with the country’s applicable legislations and regulations. This role requires cross-functional partnerships locally and internationally, to ensure that all projects have the appropriate local regulatory input and guidance.
    The ideal candidate has a solid expertise in the regulatory affairs area in South Africa along with a positive, proactive and innovative mindset.

    Roles And Responsibilities

    • Act as Deputy Responsible Pharmacist for Gilead Sciences South Africa in line with the Pharmacy Act. Provide the duties and support required of a Regulatory Affairs function on behalf of Gilead. Work is performed under consultative direction towards corporate regulatory goals and objectives.
    • Supports the regulatory strategy and manages the preparation / evaluation of all required documentation for NDAs and line extensions (including Clinical trials).
    • Manages the regulatory maintenance for the current portfolio, including annual reports, labeling updates and variations. Interacts closely with other functions/stakeholders in the organization to ensure that the regulatory strategy is robust and agreed, and any required submissions are executed within the specified timeframes.
    • Monitors regulations and changes in regulatory environment in order to keep internal stakeholders aware of risks and opportunities in a timely manner.
    • Interacts with HA and trade associations representing Gilead as necessary.
    • Supports maintenance of GMP license and Quality Agreements, as required.
    • Supports the management of the Quality Management System of the Affiliate and the maintenance of all SOPs and associated documentation as required. This includes the management of change controls, deviations and the CAPA process in the local Affiliate.
    • Initiates or supports local process improvements and contributes to local and/or global process improvements which have a significant impact for RA and other departments, assesses proposed changes to local procedural documents and impact on existing processes.
    • Manages the artwork.
    • Supports Clinical Trial Applications where required.
    • Reviews and approves promotional and non-promotional materials in accordance with local regulations, Gilead´s business conduct and South African Marketing Code
    • Acts as deputy responsible person for pharmacovigilance.

    EDUCATION And EXPERIENCE

    • B.Pharm and registration with the South African Pharmacy Council as a Pharmacist
    • Experience in South Africa Regulatory Affairs.
    • Extensive knowledge of local regulations
    • A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other functions.
    • Excellent communication skills both in writing and verbally
    • Quality Management and Pharmacovigilance experience is an advantage.

    Gilead Core Values

    • Integrity (Doing What’s Right),
    • Teamwork (Working Together),
    • Excellence (Being Your Best)
    • Accountability (Taking Personal Responsibility).
    • Inclusion (Encouraging Diversity)

    Method of Application

    Interested and qualified? Go to Gilead Sciences on gilead.wd1.myworkdayjobs.com to apply

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