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| Company: |
Medico International Recruitment - MIR |
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| Job Title: |
Regulatory Manager |
| Job category: |
Pharmaceutical |
| Job Location: |
Dubai - UAE United Arab Emirates |
| Job Description: |
A Regulatory Manager is required for a healthcare /pharmaceutical organization in Dubai.
Purpose:
Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products. Advise on and coordinate the approval and registration of pharmaceuticals.
Qualifications and Experience:
Candidates suitable for short-listing will hold a B Pharm. degree or equivalent and have RA training and certification as well as 2 years minimum proven experience in the pharmaceutical industry in a regulatory affairs environment;
Good local MOH knowledge and contacts to be able to guide Global in terms of requirements and support required;
Knowledge of MCC and other relevant regulatory requirements (such as ICH guidelines), a good understanding of issues involved in dossier compilation and broad-based appreciation of the industry as a whole including the acts and regulations governing pharmacy, will be key to your success;
Exposure to a production and/or quality assurance environment and a particular interest in regulatory affairs will be advantageous;
Knowledge of and ability to use IT software technology.
Excellent knowledge of written and spoken English and Arabic essential French as an additional language would be an advantage.
Specific Outcomes / Accountability:
Manage all submissions of the healthcare organization`s products in the region;
Determine all new requirements for the region and advise the Group and Global offices of these changes;
Liaise with the regulatory authorities in the region to resolve any issues that may arise;
Attend to product renewals in the region and ensure submission;
Attend to new product registrations in the region of the healthcare organization`s products;
Ensure all variations are submitted and approved for the healthcare organizations products within timeframes that do not allow for disruption of supply;
Assist Group Regulatory Affairs in determining validity of regional licenses and advise any requirements in order to reactivate or maintain these;
Assist with pharmacovigilence in the region for the Healthcare Organizations products;
Ensure all change controls for The healthcare organization are implemented in the region and obtain regulatory approval where required;
Liaise with counterpart in the EU to ensure that regional regulatory affairs is co-ordinate and feed information through to technical manager for consolidation;
Complete the administrative pages for any filing and liaise with in-market companies to collect dossiers and organize transfer data;
Focus on the 20 (approximately) MENA markets, develop MOH / distributor relationships and manage submissions for the healthcare organization`s products.
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Skills Required:: |
Qualifications and Experience:
Candidates suitable for short-listing will hold a B Pharm. degree or equivalent and have RA training and certification as well as 2 years minimum proven experience in the pharmaceutical industry in a regulatory affairs environment;
Good local MOH knowledge and contacts to be able to guide Global in terms of requirements and support required;
Knowledge of MCC and other relevant regulatory requirements (such as ICH guidelines), a good understanding of issues involved in dossier compilation and broad-based appreciation of the industry as a whole including the acts and regulations governing pharmacy, will be key to your success;
Exposure to a production and/or quality assurance environment and a particular interest in regulatory affairs will be advantageous;
Knowledge of and ability to use IT software technology.
Excellent knowledge of written and spoken English and Arabic essential French as an additional language would be an advantage.
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Language Requirements: |
English-GoodArabic-GoodOther: French an advantage |
| Employment Type: |
Full Time |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-04-15 |
| Level of Education: |
Unspecified |
| Years of Work Experience: |
No experience |
| Company: |
Medico International Recruitment - MIR |
| Contact Name: |
Medico International Recruitment - MIR |
| Contact Phone: |
04 361 29 26 |
| Preferred Method of Contact: |
No Preference |
| Preferred Language of Resume/Application: |
English |
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