Regulatory Support
3 months ago
Job Title:
- Regulatory Affairs SpecialistReports to (Title):
- Regulatory Assurance Lead, APAC, Middle East and AfricaDirect Reports (Titles):
- 0Number of Direct Reports:
- 0- Number of Total Employees:
- 0Business Unit/Division:
- Corporate Affairs-RegulatoryFunctional Area:
- RegulatoryJob Location:
- United Arab Emirates, DubaiLast Review Date:
Reviewer Name:
Job Summary: (Please provide two or three sentences explaining the overall role of this position.)- Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products registration/notification, renewals and updates by coordinating between internal and external stakeholders and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and approvals. The Specialist will also ensure ethical conduct and compliance with applicable national and international laws, codes and regulationsResponsibilities Include: (Please summarize the 4-8 main responsibilities/accountabilities of the position. List responsibilities in the order of importance and time spent. If possible, provide the general percentage of time spent on each responsibility.)Ensure timely registration/notification and renewal of products, Keep and maintain files and documents regarding product regulatory and compliance. Support global initiatives.Develop and maintain a product database of all products’ regulatory status in the region and ongoing registration.Plan and execute local projects and programs to meet technical and business needs within areas of responsibility based on annual performance, corporate and regional goals.Efficiently manage timelines (submissions to approval) to cope with regional and local projects & strategies as well as marketing plans through proactive communications with all relevant parties including country/region leader, RA, R&D, Marketing, Supply Chain, Sales and any other functions.Establish and maintain good relationships with Ministry of Health, Emirates Authority for Standardization and Metrology, Dubai Municipality, any other Regulatory authorities and industry associations, ensuring optimum visibility and smooth products registration.-
Write department reports, give internal presentation and prepare reports for distribution outside of the department, communicate at all levels of the company on matters of expertise. Give presentations to technical business management and write reports addressing business/compliance /policy issuesScope: (Please check relevant scope. If not applicable, leave blank. If selection does not appear in drop-down menu, hit “Esc” then “Tab” to access additional drop-down choices)
Geographic Responsibility- Budget/Size Responsibility- Global- Annual Budget:
- $Region: Middle East- Rev:$5,000,000+Country: GCC Countries- Sales Volume:
Plant/Site:
- Other:
Managerial Responsibility: (Please check one)Has no formal managerial responsibility, but may provide guidance to colleagues (e.g., provides coaching, assigns work, provides input into hiring decisions and evaluating performance).Has full managerial responsibility: has direct reports, assigns work to staff, provides coaching and training, sets goals, is accountable for performance evaluation, plans staff development, and makes and approves people management decisions either alone or in collaboration with management and P&P (including recruitment, promotions, terminations, and compensation).Typical Job Requirements: (Please check minimum education/experience required.)- Education:
- High School/Secondary- Associate/Technical- Bachelor/UniversityMasters- Doctorate- Other:
**Experience**:
- 0 - 3 Years (2-3 years)- 3 - 5 Years- 5 - 8 Years8 - 10 Years- 10 - 15 Years- 15+ YearsDegree, Certification, Training and Language Preference/ Requirement-
- Bachelor of Science (BSc)
- Fluent in English and Arabic (speak and write)Soft Skills (desired)-
- Able to clearly express oneself orally and in writing. Effective and routinely communication at department level and with business managers.
- Hands-on and able to work independently. Highly organized with a keen sense of what it takes to get the job done; strong operating skills and a sense of urgency.
- Extensive knowledge of RA environment (processes, organization, legislation) in the ME.
- Must have strong collaborations skills, the ability to work in a cross-cultural organization and experience working in a partnership environment.
- Strong mental agility and motivation are required to deal with the variety of product categories and market access strategies.
- Strong interpersonal skills are mandatory for this position; communication, business and customer-oriented approach and ability to build relationship with external contacts.Success Metrics (desired)- Objective : e.g Awards/success ;Personal achievements- Subjective : e.g Pride in accomplishments, meaningful company mission ; on a persona
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