Regulatory Affairs Executive
1 month ago
**Job Summary**:
**Key Responsibilities**:
- **Regulatory Strategy and Compliance**:
- Develop and implement regulatory strategies for new product registrations, renewals, and variations.
- Ensure all company products comply with applicable regulations, standards, and guidelines, including FDA, EMA, MHRA, TGA, and other relevant regulatory bodies.
- Maintain current knowledge of regulations, guidelines, and standards applicable to company products and proactively communicate relevant updates.
- **Regulatory Submissions and Documentation**:
- Oversee and manage submission timelines, ensuring timely responses to regulatory agency questions and requirements.
- Conduct detailed reviews of labeling, promotional materials, and other documents to ensure regulatory compliance.
- **Liaison and Communication**:
- Act as a key contact with regulatory authorities, handling inquiries and maintaining positive relationships to facilitate approvals.
- Collaborate closely with cross-functional teams, including R&D, quality, clinical, and marketing teams, to ensure alignment on regulatory objectives and strategies.
- Support and guide internal teams on regulatory issues and compliance requirements.
- **Risk Assessment and Change Management**:
- Identify regulatory risks associated with product development and commercialization and provide recommendations to mitigate these risks.
- Manage changes to products, labeling, and other critical areas to ensure continuous compliance with regulations throughout the product lifecycle.
- **Post-Market Surveillance and Reporting**:
- Oversee post-market activities, including adverse event reporting, field safety notices, and recalls, if necessary.
- Ensure compliance with pharmacovigilance or post-market surveillance requirements.
- **Documentation and Record Keeping**:
- Maintain accurate records of regulatory submissions, correspondence, and related documents.
- Prepare and maintain regulatory reports, summaries, and presentations as needed.
**Qualifications and Skills**:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
- Strong knowledge of regulatory guidelines and processes for major regulatory bodies (e.g., MOH-UAE, DOH, DHA, FDA, EMA, MHRA).
- Excellent organizational skills, with the ability to manage multiple projects and deadlines.
- Strong attention to detail and analytical skills.
- Proficiency in regulatory information management systems (RIMS) is preferred.
- Strong communication and interpersonal skills for effective collaboration with both internal teams and external regulatory agencies.
**Job Location**:
Dubai
**Salary Range**:
3000-5000
Pay: AED3,000.00 - AED5,000.00 per month
-
Regulatory Affairs Executive
6 months ago
Dubai, United Arab Emirates TheSay Pharma General Trading Full time**Regulatory Affairs Executive immediate Joining.** **Requirements**: Post graduate in pharmacy or life sciences with at least 3 years experience in medical device regulatory affairs, Regulatory Affairs 3-4 Years of experience in UAE Registrations, Must have knowledge about dossiers and Handling of e-CTD software. Exposure to DMF preparation, regulatory...
-
Regulatory Affairs Executive
6 months ago
Dubai, United Arab Emirates Robustrade DMCC Full time**Scientific Office Pharmacist - Regulatory Affairs Executive** You will be responsible for the regulatory affairs function for an assigned territory of the UAE & GCC region. **Relevant skills, Experience & Knowledge**: Experienced in Conventional Medicines with eCTD submissions, GSL, Herbal, Medical Devices Pharmaceutical Products in MOHAP. The primary...
-
Executive - Regulatory Affairs
1 month ago
Dubai, United Arab Emirates STERLING PERFUMES INDUSTRIES Full timeResponsible for ensuring regulatory compliance related activity for perfume products. You will supporting quality manager to complete full activity relating to Regulatory Affairs. **Job Types**: Full-time, Permanent Pay: AED3,000.00 - AED3,500.00 per month
-
Regulatory Affairs Intern
7 months ago
Dubai, United Arab Emirates Abbott Laboratories Full time**About** **Abbott** Abbott 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** **Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and...
-
Regulatory Affairs Manager
6 months ago
Dubai, United Arab Emirates AstraZeneca Full time**JOB TITLE** **Regulatory Affairs Manager** **ABOUT ASTRAZENECA** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical...
-
Regulatory Affairs Manager
6 months ago
Dubai, United Arab Emirates Biogen Full timeThe incumbent will work in close collaboration with GCC Regulatory and commercial organizations, as well as relevant local stakeholders. This role reports directly into the Head of Regulatory Affairs - GCC Cluster. **Registration Planning** - Work according to the strategic directions defined by the Head of Regulatory Affairs - GCC and in line with GCC...
-
Regulatory Affairs Officer
3 months ago
Dubai, United Arab Emirates WeSource Human Resources Consultancy Full time**Role: Regulatory Affairs Officer** - For 3 months - Location: Dubai - Salary: Open **Qualifications**: Bachelor's degree in Pharmacy or Biotechnology or relevant Sciences from a reputed University **Experience and Professional Requirements**: - Minimum 5 years of experience in the pharmaceutical/biotechnology/life science industry of which 4+ years of...
-
Associate Manager Regulatory Affairs
6 months ago
Dubai, United Arab Emirates Ipsen Pharma (SAS) Full time**Job Description Summary*** Supports MEA Regional Director of Regulatory Affairs & Scientific Office. Ensure product regulatory compliance with applicable regulations and standards in MEA. **Main** **responsibilities** **/** **job** **expectations** Works autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific...
-
Regulatory Affairs Graduate Intern
4 months ago
Dubai, United Arab Emirates Abbott Laboratories Full time**About** **Abbott** Abbott 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** **Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and...
-
Regulatory Affairs Manager
6 months ago
Dubai, United Arab Emirates Givaudan Full timeStep into our world of creativity and joy! Regulatory Affairs Manager - Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There’s much to learn and many to...
-
Government & Regulatory Affairs Professional, UAE
6 months ago
Dubai, United Arab Emirates IBM Full timeIntroduction At IBM, work is more than a job - it's a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you've never thought possible. Are you ready to lead in this new era of technology and solve some of the world's most...
-
Manager, International Regulatory Affairs
8 months ago
Dubai, United Arab Emirates Amazon Middle East and North Africa FZ-LLC - F52 Full timeBachelor’s degree in electrical engineering or other relevant discipline (e.g., communications). - Experience related to spectrum management experience, securing licenses for the provision of telecommunications services and ensuring regulatory compliance at an international level. - General knowledge of satellite communications systems and services and...
-
Regulatory Affairs Manager
8 months ago
Dubai, United Arab Emirates Abbott Laboratories Full time**About Abbott** Abbott 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 Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full...
-
Head of Regulatory Affairs Meta
6 months ago
Dubai, United Arab Emirates Galderma Full timeWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Regulatory Affairs Officer/assistant
6 months ago
Dubai, United Arab Emirates Biotech Pharma LLC Full timeA global pharmaceutical company that has been providing a wide range of specialized products around 70 countries for more than 40 years is currently looking for well organized, time oriented, hard working and committed individual to fulfil the responsibilities of RA Officer/Assistant - Pharmacy graduate with MOH license having 1-2 years of experience in...
-
Regulatory Affairs Officer
6 months ago
Dubai, United Arab Emirates The Stunning House Full time**What You'll Do** - Performing Product Registration in UAE and obtain all registration requirements as needed in all GCC - Prepare and submit registration dossiers to regulatory agencies for product approval (montaji system, eCDT ) and maintain all required documentation - Coordinate with cross-functional teams to ensure regulatory compliance in all aspects...
-
Accountant - Judicial Execution Affairs
1 month ago
Dubai, United Arab Emirates The Government of Dubai Legal Affairs Department Full timeIntroduction: The Government of Dubai Legal Affairs Department (The Department) wishes to recruit an Accountant in judicial execution affairs at Support Services Directorate for undertaking accounting procedures relevant to judgments and writs of execution in a manner that ensures compliance with laws and financial regulations applicable in the Government of...
-
Regulatory Affairs Manager
6 months ago
Dubai, United Arab Emirates Skyports Full time**About Skyports**: Founded in 2018, Skyports is an Advanced Air Mobility company developing and operating landing infrastructure for the electric air taxi revolution, as well as using drones for a variety of business requirements. Our business is comprised of two entities. - Skyports Drone Services_ where we use drone technology to enable businesses to...
-
Regulatory Affairs and Labelling Associate
1 month ago
Dubai, United Arab Emirates Aspen Pharma Group Full time**ROLE PURPOSE**: - Execute regulatory affairs activities to meet departmental and business goals while ensuring compliance with health authority regulations in assigned markets. - Ensure alignment with the company’s internal procedures for regulatory standards. - Define, determine, and communicate regulatory requirements and due diligence to stakeholders...
-
Veterinary Regulatory Affair Officer
5 days ago
Dubai, United Arab Emirates Smart vets general trading llc Full time**Regulatory Strategy and Compliance**: - Develop and implement regulatory strategies for new product registrations, renewals, and variations. - Ensure all company products comply with applicable regulations, standards, and guidelines, including MOCCA - Maintain current knowledge of regulations, guidelines, and standards applicable to company products and...