Regulatory Affairs Executive
1 week ago
REGULATORY AFFAIRS EXPERIENCED
- Coordinate with project lead and stakeholders to assess and define projects scope, requirements and timelines for proper planning and execution.
- Act as a point of contact and communicate project status with countries.
- Coordinate with Logistics/ Supply Chain/ Labeling teams and manufacturing site to obtain valid artworks and implementation dates.
- Arrange and request all needed documents and certificates for files submission to Health Authorities.
- Prepare submission dossiers and publish eCTD as per countries requirements and regulations.
- Coordinate and followup with countries to ensure timely submission as per plan.
- Support countries in Health Authorities' queries to secure speedy approvals.
- Update project trackers and proper archiving for documents and dossiers.
- Comply with all internal SOPs and trainings.
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regular follow up on the submitted files.
- Ensure timely submissions as well tightly manage deficiency responses. Priority will be given to the positive margin products.
- Feed the trackers provided by APTL/ group/ AGI with accurate information and provide them with input for any regulatory plan rolled out.
- Work with the regulatory affairs manager to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries.
- Work with the regulatory affairs manager to develop and execute regulatory plans for complex projects including transfer of the newly acquired products, tech transfers and maintenance of licenses/authorizations for existing marketing authorizations.
- Work on Renewals (products and sites) submit the request as per the date mentioned in the renewal tracker. Renewal planned submission date should be met.
- Coordinate Regulatory Affairs filing for all Aramed Group Products.
- Regulatory concerns to be addressed and reported whenever required.
- Maintaining periodic updates on the changes from supplier(s)
- Visiting MOHAP, Dubai Municipality and relevant offices for their direct influence on company concerns.
- Notification sharing to regional team and to record their response to queries.
- Assist in Professional license renewals and facility license renewal with MOHAP
- Communicate and build relations with Key officials in Government department of RA for a smooth processing.
- Maintain Report on Submission and track updating on daily basis.
- Submit reports to Manager on monthly basis
- Bachelor's degree in Science
- Mandatory experience in Regulatory affairs derma/aesthetic
- Mandatory Arabic speaker
- Preference with the driving license in KSA
- Strong people management skills
- High level of interpersonal skills
- Excellent planning, organising and prioritising skills
- Ability to make decisions
- Ability to use initiative
- Ability to implement and ensure compliance with company policies & procedures
Salary:
ریال8, ریال10,000.00 per month
Ability to commute/relocate:
- Muscat: Reliably commute or planning to relocate before starting work (required)
Education:
- Bachelor's (preferred)
Experience:
Regulatory Affairs: 2 years (preferred)
- Pharmacists: 2 years (preferred)
- Pharmaceutical: 2 years (preferred)
- Medical Equipment's: 2 years (preferred)
Language:
- Arabic (preferred)
License/Certification:
- Driving License (preferred)
- Pharmacist (preferred)
-
Regulatory Affairs Specialist
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Genesis Executive Full timeThis role is based in Riyadh, Saudi ArabiaOverviewResponsible for regulatory affairs activities to assist in regulatorysubmission, annual reports, registrations and listings. Assurecompliance with applicable medical device regulations per jurisdiction,guidance and standards. Assist in creation and maintenance ofregulatory files.Job ResponsibilitiesWrite,...
-
Regulatory Affairs
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Radiometer Full timeIn our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating...
-
Regulatory affairs specialist
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Alewan Full timeWe are looking to hire Regulatory Affairs Specialist to be a part of our Regulatory Affairs team.Requirements:2-3 years' experience in pharmaceuticals registration is mandatoryFood Supplements and medical devices are added benefit.Aware of SFDA Requirements and regulation.Excellent organizational and presentation skills.Proactive and Punctual.Location:...
-
Regulatory Affairs Coordinator
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Boston Scientific Corporation Full timeRegulatory Affairs Coordinator - Tamheer Program:Remote Eligible: HybridOnsite Location(s): Riyadh, SAWork Location : Riyadh, Saudi ArabiaKey Responsibilities: Give support on regulatoryrelated issues associated with compliance and achieving the business plan. Will be introduced to product registration planning and prioritization for his/her respective...
-
Regulatory Affairs Manager
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Al Safa Pharmaceutical Store Full timeRegulatory Affairs Manager:- Job SummaryTasks and Responsibilities- contributing to the organization's strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters;- writing and periodically updating drug regulatory affairs (DRA)-related local SOPs;- reviewing draft registration files and submitting new and...
-
Regulatory Affairs Lead
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Johnson & Johnson Full timeAbout Johnson & Johnson:For our Local Operating Company in Saudi Arabia, we are currently recruiting for a Regulatory Affairs Expert to be based in our Riyadh office. In this role you will be leading our Regulatory activities across the region, as well as support a team based across the KSA and Gulf cluster. This role is an excellent opportunity for...
-
Regulatory Affairs Executive/specialist
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Zahrawi Medical Full timeAbout Zahrawi Group:Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.job Brief: The incumbent is responsible for all Product...
-
Senior Regulatory Affairs Manager
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Biogen Full timeJob Description Purpose**: The incumbent will work in close collaboration with GCC Regulatory and commercial organizations, International Growth markets (IGM), Development, Chemistry, Manufacturing and Control (CMC) Regional contacts as well as relevant global, regional and local stakeholders.He/she will lead local regulatory activities in KSA to ensure...
-
Regulatory Affairs Specialist Middle East
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Abbott Laboratories Full timeAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.You will...
-
Regulatory Affairs Supervisor
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia MS Pharma Injectable Full timeYou must first log in before applying to jobs. The Regulatory Affairs Supervisor is responsible for preparing registration dossiers for new products, line extensions, and new indications. They will also be responsible for maintaining the license of existing registered products by managing all regulatory activities throughout the product lifecycle.Main...
-
Regional Regulatory Affairs Specialist
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Dexcom Full timeAbout DexcomFounded in 1999, Dexcom, Inc (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...
-
Regulatory Affairs ExecutiveSpecialist
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Precision Hire Solution Full timeAbout Zahrawi GroupZahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE KSA Qatar Bahrain & Oman markets. The company supplies and distributes highquality products and services to Hospitals Clinics Laboratories & Analytical Industries. job Brief The incumbent is responsible for all Product Classification/Manufacturing...
-
Regulatory Affairs Manager
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Abbott Laboratories Full timeJob TitleRegulatory Affairs ManagerAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true...
-
Riyadh, Ar Riyāḑ, Saudi Arabia Philips Full timeJob TitleRegulatory Affairs Manager, Hospital Patient Monitoring METAJob DescriptionJob title:Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.You are responsible for Create regulatory awareness level as determined within the organization. Supports implementation of simplified yet robust...
-
Riyadh, Ar Riyāḑ, Saudi Arabia Philips Full timeJob TitleRegulatory Affairs Manager, Hospital Patient Monitoring METAJob DescriptionJob title:Main point of contact between BU, Market and Local Business Team for product registration preparation and renewals.You are responsible for Create regulatory awareness level as determined within the organization. Supports implementation of simplified yet robust...
-
Regulatory Affairs Specialist
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Haleon Full timeHello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human...
-
Regulatory Affairs Manager
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Mindfield Resources Full timeJob Description:Your role: As an integral part of the team, your role would entail overseeing day-to-day operational activities, and collaborating with both internal and external stakeholders to ensure timely submission and approvals of regulatory activities while proactively communicating the progress of such activities. Your deep understanding of the...
-
Regulatory Affairs Manager
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Mindfield Resources Full timeJob Description:Job description:Your role :As an integral part of the team, your role would entail overseeing day-to-day operational activities, and collaborating with both internal and external stakeholders to ensure timely submission and approvals of regulatory activities while proactively communicating the progress of such activities. Your deep...
-
Government Affairs Director
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Precision Hire Solution Full timeMicrosoft has an immediate opportunity for a highly skilled experienced government affairs professional to join the Corporate External and Legal Affairs (CELA) team in Saudi Arabia as a Government Affairs manager. The successful candidate will report to the Middle East CELA Lead. Microsofts mission is to empower every person and every organization on the...
-
Reg Affairs
1 week ago
Riyadh, Ar Riyāḑ, Saudi Arabia Boston Scientific Corporation Full timeReg Affairs - P4: Work mode: Hybrid Onsite Location(s): Riyadh, SAAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most...