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    regulatory affairs officer - Aalst, België - Ferring Pharmaceuticals

    Ferring Pharmaceuticals
    Ferring Pharmaceuticals Aalst, België

    4 dagen geleden

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    Beschrijving

    Job Description:

    About us

    As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

    Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals. Together we can influence the world around us to make life and work better.

    Ferring+You

    As Regulatory Affairs Officer your role is to ensure Regulatory, Quality Assurance, Pharmacovigilance, and medical information for products on the Belgium and Luxembourgish markets.

    Your day at Ferring

    Regulatory Affairs:

  • Marketing Authorisation application, variation, renewal:Review of documentation provided by headquarters.Preparation of local documents required for the submission of MAs, variation, renewal...Ensure timely submission of the registration files by using the Ferring platforms to create necessary packages
  • Communication with health authorities in Belgium and Luxembourg regarding submission

    • Quality Assurance:

  • Ensure complaints are enregistrered in timely matter for investigation by manufacturerUse of TrackwiseEnsure samples are returned by customers for investigation and sent to site for investigation
  • Ensure deviations are enregistrered in timely matter
  • Support revision of SOPs and training of these
  • Prepare documentation for release for distribution of batches

    • Pharmacovigilance:

  • Ensure timely submission of adverse event cases to corporate
  • Ensure information required for correct reporting of cases is obtained from reporters
  • Perform review of local literature

    • Medical information:

  • Support sales force with regards to request for samples (including follow up on creation of samples by LSP)
  • Create MA documents required for promotional material
  • Maintain register with medical questions

    • Non-exhaustive list of tasks and responsibilities that may be expanded in response to the evolution of legislation and requirements in RP / QA / RA and Pharmacovigilance / Publicity in Belgium and GH Luxembourg.

    Behind our innovation...There's You

    EDUCATION

  • Pharmacist

    • EXPERIENCE & QUALIFICATIONS

  • Minimum 2-3 years' experience
  • Knowledge and skills in Regulatory Affairs procedures, QA & PV principles, knowledge of GDP or willing to develop in these areas.
  • Fluent in Dutch, French and English

    • SKILLS, ABILITIES & KNOWLEDGE

  • Good analytical skills with an eye for details, hands on mentality
  • Proactive
  • Sociable
  • Open to digital transformation, changes and learning and able to network both internally and externally

    • BACK UP ROLES

  • Local RP – Responsible pharmacist Belgium-Luxembourg back-up
  • Local responsible person pharmacovigilance back-up
  • Materiovigilance contact point back-up

    • People come first at Ferring

    Our philosophy of "People come first at Ferring" is lived through every part of our business. ​Our mission is to develop treatments to care for others, while we also care for each other. We offer competitive total compensation, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work.

    We want you to enjoy all that life has to offer, along with purpose-driven work. We have created an inclusive and flexible environment allowing employees to work both remotely and on-site, with unique benefits for employees and their families to live their best lives. ​

    Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member's contributions. Imagine the power of your career when it's Ferring + You.

    Behind our purpose... There's you

    If our mission and your vision are aligned, please apply

    We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.

    Site:

    Ferring Belgium (Aalst / Brussels periphery)

    Location:

    Ferring Belgium
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