Regulatory Affairs Supervisor
Abu Dhabi, United Arab Emirates
Job Description
A multinational pharmaceutical company is actively recruiting a Regulatory Affairs Supervisor to be based in Abu Dhabi, UAE. Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion. Key aspects of the role include:
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- Prepare and complete the registration process for assigned products.
- Approvals & maintenance of regulatory licenses and applications.
- Reviewing new product submission and variation dossiers for submission.
- Collate and distribute all technical and regulatory documentation internally and externally.
- Prepare and maintain relevant SOPs.
- Defining and execute regulatory plans and manage timelines to achieve the stated goals.
- Ensures timely preparation, submission, and appropriate follow-up of new applications to the local authorities.
- Maintenance of assigned, authorized products through timely submission of variations, renewal applications.
- Updated on relevant local regulations and guidelines.
- Collects relevant regulatory information.
- Maintain a positive relationship with internal and external regulatory contacts.
- Bachelor\xe2\x80\x99s or master\xe2\x80\x99s degree in pharmacy or similar.
- Must have a minimum 10 years\xe2\x80\x99 Regulatory Affairs experience in a biotech/pharmaceutical industry. Previous experience working with international regulatory organizations.
- Proven Experience and knowledge in regulatory submissions. Preferably Marketing Authorization Application
- Strong Knowledge and understanding of GCC, FDA and EMA regulations.
- Performance-driven individual, with a strong sense of urgency, exceptional organizational credibility, and deep understanding of the business.
- Excellent verbal and written in English.
- Applicants should be available for face-to-face interviews in the location mentioned above.
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Job Detail
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Job IdJD1502008
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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 LocationAbu Dhabi, United Arab Emirates
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EducationNot mentioned