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  • Posted: Dec 16, 2019
    Deadline: Not specified
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    Ferring Pharmaceuticals is a research-driven, biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. The company's research activities and products are connected by a common focus of providing tailored treatments that wo...
    Read more about this company

     

    Coordinator, Regulatory Affairs

    Job Purpose:
    To implement regulatory strategies to deliver timely submissions and approvals of key business assets. Maintain regulatory and quality compliance by alignment with internal company processes and procedures. Drive positive regulatory change in SSA through networking and influencing.

    Essential Job Responsibilities
    Regulatory

    • Implement regulatory strategic programs to drive speedy marketing authorizations for Ferring pharmaceutical products, including NCEs and line extensions/new indications, in alignment with market commercial objectives/priorities in addition to registration maintenance activities
    • Active involvement with regional project teams to improve internal processes.
    • Support training and education programs with local regulatory contacts/NSM (National sales managers), by organizing and chairing regional regulatory Meetings, to ensure understanding and compliance of company regulatory processes, including timely management of product updates.
    • Challenge unfavorable pharmaceutical legislation. Network and establish influential relationships with national and/or international governments and trade associations, to achieve advantage for Ferring and the industry by helping to shape the regulatory environment in the SSA Area. This includes being involved in the Africa Regulatory Network (ARN), which comprises of regulatory managers from research based pharmaceutical companies.
    • coordinate and Follow up the SSA regulatory expenses and budget with LOC’s (local Operating company)/META (Middle East Africa and Turkey)
    • Maintain an up to date SSA data base, with all regulatory guidelines, submission/GMP fees, approval timelines

    Quality and others

    • Coordinate with META, to implement quality processes to support the business activities, and be aligned with corporate (QMS) and local market policies.
    • Coordinate all PV activities

    Candidate basic requirements and Qualifications:

    • A scientific background – degree and or higher degree in Medical/pharmaceutical sciences
    • Experience and understanding of regulatory processes in the developed and developing world (Kenya, and some other SSA countries).
    • Good understanding of technical and manufacturing issues
    • Good commercial understanding and appreciation.
    • Achievement, results driven
    • proven Communication, and negotiation Skills
    • External Knowledge – products, therapy, environment, DRA
    • Must be prepared to travel within territories in SSA.
    • The incumbent should at least have 2 years’ experience of Research based Pharma Industry in Kenya or/and other SSA countries.

    Must be fluent in English, and Swahili. Good knowledge of French will be appreciated.


     

    Method of Application

    Interested and qualified? Go to Ferring Pharmaceuticals on ferring.wd3.myworkdayjobs.com to apply

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