الصفحة الرئيسية الإمارات العربية المتحدة Regulatory Affairs Manager
الصفحة الرئيسية الإمارات العربية المتحدة Regulatory Affairs Manager
Regulatory Affairs Manager
تفاصيل الوظيفة
A leading Pharma distributor in Dubai is looking for a Regulatory Affairs Manager. Regulatory & Compliance
- Ensure compliance with Ministry of Health regulations to support appropriate regulatory strategy
- Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy
- Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications
- Provide expert regulatory input to in-licensing evaluations and due diligence activities
- Manage and facilitate all registration related activities
- Regular review of regulatory documentation and technical product information
- Provisions of regulatory support for portfolio of products
- Proactive supervision of product & companies licenses
- Establish & update registration data base in the company.
- Update licensing and collect information on registration instructions and regulations
- Complete forms and requests originating from government agencies (MOH)
- Carry out all subsequent follow up and pricing negotiations necessary to obtain the approval
- Checking all import permits and ensuring approval of import permits by MOH.
- Provide the Logistic teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
- Follow up on drug safety on all “ Pharmacovigilance” issues
- Update MOH with new safety data from Principal companies/update drug companies on new PV regulations by MOH
- Submit annual safety reports for companies to MOH.
- Deal with quality related questions and complaints
- Follow up and update all existing registration dossiers & handling minor change variations that crop up
- Timely accurate solutions to all complaints
- Outlining requirements for labelling, storage and packaging
- Conduct business development registration analysis for new business opportunities
- Study the possibility of new business development in terms of registration possibility/classifications
- Discuss with MOH new product/company registration in terms of Regulatory aspects of company/products.
- Gathering, evaluating, organising, managing and collating information in a variety of formats that may help the business.
- Establish healthy & effective relationship with all concerned personnel at MOH.
- Maintain professional relationship with regulatory authorities
- Communicate with regulatory bodies in Ministry of Health to facilitate successful product launch.
- Ongoing visits and intensive call to all concern people.
- Bachelor’s Degree in Pharmacy from a recognized University/Institution.
- MOH & DOH, FPGEE License Holder
- Knowledge & experience of regulatory process
- Knowledge of MOH and government regulations relevant to our products
- Proficient in MS Office, especially Excel and Power Point
- Language Skills: Fluency in English and Arabic
- 5-8 years of relevant experience in Regulatory Affairs in Pharmaceutical / Healthcare industry
- Skilled at managing ambiguity, influencing without authority and achieving results
- Strong interpersonal skills
- Self-motivated with the ability to prioritize tasks and work effectively with others
- Understanding tolerances and variations
- Demonstrate excellent judgment and analytical skills
- Strong communication skills (written and verbal)
- Strong attention to details
- Ability to adapt to changing environment/priorities
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Quality Assurance
- Industries
- Medical Practices and Pharmaceutical Manufacturing
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الشركة المعلنة عن الوظيفة
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