Regulatory Affairs Associate
Ismailia, Egypt
Job Description
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Purpose of the position
- The Regulatory Affairs Associate III is a project manager (PM) responsible for new registrations for Teva own developed products, for achieving Marketing Authorization (MA) for the Medis business.
- The PM is either assigned to specific products or markets.
- The PM is responsible for planning, preparing and/or submitting Marketing Authorization Applications (MAAs) to regulatory authorities and/or Medis clients.
Responsibilities
- EU/EEA markets: Plan, prepare and submit MAA to health authorities (DCP/MRP/National) or third party clients.
- International markets (non-EU): Provide Medis clients with support for MAA submissions.
- Coordinate and contribute to the response to deficiency from health authorities and act as key contact between R&D, Site RA, Clinical team, Medis clients and other functions as relevant.
- Monitor timelines and coordinate relevant flow of information to internal and/or external contacts during the registrations process until end of procedure or MA approval.
- Define CPP strategy and screening of Teva´s MAs for international markets.
- Ensure the most up to date regulatory dossier is provided by working closely with the Harlow team and relevant site RA teams. Consolidate the dossier from eCTD sequences if not available in “master” format.
- Provide regulatory guidance/support to Medis.
- Database updates and other document management systems/lists.
- Work on other specialised projects as defined by managers of Medis RA.
- Organise audit of dossiers and due diligence to clients.
- Regular status updates to management.
Qualifications
- BSc/MSc required preferably in pharmaceutical sciences
- Experience in regulatory affairs is preferred
- Excellent organizational skills
- Excellent communication and presentation skills
- Excellent written and verbal knowledge in English
- Strategic thinking and flexibility to adapt to changes
- Strong team player
- Good computer skills
Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To
Director Regulatory Affairs
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
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Job Detail
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Job IdJD1406953
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationIsmailia, Egypt
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EducationNot mentioned