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Regulatory Affairs Specialist

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Omrix Bio-pharmaceuticals is seeking a Regulatory Affairs Specialist

**This position is a replacement of maternity leave, The duration of the position will be 9 months**

JOB SUMMARY

Coordinates, compiles, and submits new product applications, investigate new product applications and post approval supplements to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies’ questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new product application and investigate new product applications.

 

DUTIES & RESPONSIBILITIES

  • Review and provide WW regulatory assessment for changes in approved product (CCs, Supplier notifications, New projects)
  • Prepares and submit required regulatory applications for new products and maintenance of existing products with limited supervision.
  • Prepare and maintain an annual and periodic plans of activities
  • Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters with limited supervision.
  • Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
  • Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc. with limited supervision.
  • Monitors and submit regulatory applications for changes of approved products with limited supervision.

 

EXPERIENCE AND EDUCATION

  • A minimum bachelor’s degree – Pharmacy, Biology, Biochemistry, Chemistry
  • 3 years of progressive experience in Regulatory Affairs, preferably in biological or drug products.

 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.

  • Leverages a working knowledge of the regulatory environment to prepare compliant Regulatory strategies and scientific and technical understanding of medical devices to provide regulatory input to product life-cycle management and evaluate regulatory impact on products.
  • In depth understanding of Omrix manufacturing processes, analytical testing and
  • Provide Regulatory Affairs support: Generates and manage submission documents for new products or changes to existing files.
  • Must be able to proactively develop partnerships and alliances across the business.
    Engages with external stakeholders and demonstrates conviction, pro-activity and persistence when influencing others and overcoming resistance. Creates compelling negotiating positions that builds support and consensus among key stakeholders. And builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.
  • Track requirements of regulatory agencies and implement file updates accordingly
  • and long-term decisions and activities. Demonstrates an enterprise-wide mindset.
  • High level English

 

Occasionally  Business Travels

 

אומריקס הינה חברה ביו-טכנולוגית המייצרת ומפתחת מוצרים מצילי חיים ב- 2 תחומים: ביוכירורגיה וחיסונים פאסיביים. החברה נוסדה ב 1995 ומתמחה בפיתוח וייצור של מוצרים ביוטכנולוגיים מתקדמים מפלסמה אנושית. אומריקס מועסקים מעל 500 עובדים בישראל, בשלושה אתרים מרכזיים: תל השומר, הר החוצבים ירושלים ונס ציונה.

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