Regulatory Affairs Manager
4 weeks ago
This role is essential to supportingthe growth of the medicinal product portfolio while leading atalented team of regulatory professionals.
KeyResponsibilities:
- Manageand lead a team of Regulatory Affairs officers, ensuring timely andefficient regulatory submissions, including Marketing AuthorizationTransfers, CMC variations, labelling updates, andrenewals.
- Act as the primary point of contactwith regulatory authorities, ensuring clear and effectivecommunication for all assignedprojects.
- Collaborate closely with distributionpartners to meet regulatory needs, plan variations, and updatemarketing authorization dossiers.
- Stayup-to-date with international regulatory guidelines, promotingcompliance and best practices across theteam.
- Drive process improvements, manageregulatory tools and platforms, and maintain regulatorydatabases.
- Prepare monthly status reports,project metrics, and workload forecasts to ensure transparency andeffective tracking of timelines and budgets.
The SuccessfulApplicant
The ideal candidatefor the role will have:
- APharmacy degree or equivalent, with a Master's inRegulatory Affairs.
- 7-10 years of experience inRegulatory Affairs, with a proven track record of teammanagement.
- The candidate needs to be based inUAE with strong experience working in thecountry
- Experience in a multinationalenvironment, with a focus on regulatory strategy across the MiddleEast and Asian markets.
- In-depth knowledge ofregulatory documentation, time lines, andbudgeting.
- Excellent communication andleadership skills, with the ability to thrive in a multiculturalenvironment.
- Fluency in English is required;French and Arabic language skills are a plus.
RegulatoryKnowledge: In-depth understanding of relevant laws,regulations, and guidelines (e.g., FDA, EMA, ISO standards) relatedto theindustry.
AnalyticalSkills: Strong ability to analyze complexregulations and assess their impact on products and businessoperations.
Attentionto Detail: Precision in reviewing documents,submissions, and compliance reports to ensure accuracy andadherence to regulatoryrequirements.
CommunicationSkills: Excellent verbal and written communicationabilities for effectively liaising with regulatory agencies,internal stakeholders, and cross-functionalteams.
ProjectManagement: Proficiency in managing multipleprojects, timelines, and deliverables while ensuring compliancedeadlines aremet.
Problem-SolvingSkills: Capability to identify compliance challengesand develop practical solutions to addressthem.
InterpersonalSkills: Strong relationship-building skills tocollaborate with regulatory agencies, industry groups, and internaldepartments.
StrategicThinking: Ability to align regulatory strategieswith business objectives, providing insights that support productdevelopment and marketentry.
ContinuousLearning: Commitment to staying updated on changesin regulations, industry trends, and best practices in regulatoryaffairs.
RiskManagement: Understanding of risk assessment andmitigation strategies related to product compliance and marketintroduction.
-
Regulatory Affairs Manager
3 weeks ago
Dubai, Dubai, United Arab Emirates ClickJobs Full timeJob DescriptionTakeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements:Master's degree in Regulatory Affairs or related field plus 2 years of related experience.Prior experience must include:Developing the regulatory submission strategies for products in commercial and...
-
Regulatory Affairs Associate
22 hours ago
Dubai, Dubai, United Arab Emirates KinTec Recruitment Ltd Full timeWe are looking for a highly skilled Regulatory Affairs Associate to join our team at KinTec Recruitment Ltd. As a Regulatory Affairs Associate, you will be responsible for ensuring compliance with local regulations and standards in relation to NOCs and building permits for industrial developments in Abu Dhabi, UAE.You will work closely with project managers,...
-
Regulatory Affairs Manager
7 days ago
Dubai, Dubai, United Arab Emirates Property Finder Group Full timeBachelor's degree in Business Administration, Political Science, Public Relations, or related field required; MBA or law degree preferred.A minimum of 5 years of experience in advocacy or public policy is required. Excellent Project Management Skills and use of PM tools, public speaking, communication skills, presentation skills, data translation skills,...
-
Regulatory Affairs Manager
6 days ago
Dubai, Dubai, United Arab Emirates Emirates Flight Catering Full timeAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our quality team at Emirates Flight Catering. The successful candidate will be responsible for ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Conduct Quality Audits of Suppliers and provide audit reports.Review and recommend...
-
Regulatory Affairs Specialist
6 days ago
Dubai, Dubai, United Arab Emirates Robert Walters Full timeAbout the RoleWe are looking for a talented Regulatory Affairs Specialist to join our team at Robert Walters. This role involves liaising with regulatory bodies and maintaining relationships to ensure compliance with current and future regulatory requirements.Main Responsibilities:Liaise with regulatory bodies to stay up-to-date on current and future...
-
Regulatory Affairs Manager
7 days ago
Dubai, Dubai, United Arab Emirates unicareuae Full timeWe are looking for a Regulatory Affairs Manager to support the implementation of GxP standards in our warehouse.Key Responsibilities:Liaise with Operations teams to ensure full compliance with established procedures and guidelines.Investigate and report on accidents, incidents, and near-misses within the warehouse.Develop and implement training programs...
-
Regulatory Affairs Associate Director
3 weeks ago
Dubai, Dubai, United Arab Emirates Gilead Sciences, Inc. Full timeRegulatory Affairs Associate Director - Gulf RegionJob DescriptionRegulatory Affairs Associate Director, Gulf Countries, based in the UAEWe are looking for a unique individual who is passionate about advancing therapeutics, with creative problem solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an exciting...
-
Regulatory Affairs Specialist
2 days ago
Dubai, Dubai, United Arab Emirates GlaxoSmithKline Full timeAbout the roleWe are seeking a highly skilled Regulatory Affairs Associate to join our team at GlaxoSmithKline (GSK). As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with local regulations and securing regulatory approval in GNE markets.The successful candidate will have excellent knowledge of Microsoft...
-
Head of Regulatory Affairs
21 hours ago
Dubai, Dubai, United Arab Emirates Aventus Full timeThe Aventus Group is a leading provider of financial services in the DIFC. We are currently seeking a Head of Regulatory Affairs to join our team. As a key member of our organization, you will be responsible for ensuring compliance with all relevant regulations and laws.You will work closely with our senior leadership team to develop and implement effective...
-
Regulatory Affairs Manager Position
3 days ago
Dubai, Dubai, United Arab Emirates ClickJobs Full timeJob DescriptionTakeda Development Center Americas, Inc. is seeking a skilled professional to join our team as a Manager, Global Regulatory Affairs CMC in Cambridge, MA.About the RoleThis exciting opportunity involves developing and implementing regulatory strategies for commercial and development phase products in close collaboration with quality,...
-
Pharmaceutical Regulatory Affairs Manager
7 days ago
Dubai, Dubai, United Arab Emirates Aramed Full timeAt Aramed, we are seeking a highly skilled Regulatory Affairs Executive to join our team.Job OverviewThis is an exciting opportunity for a professional who can ensure compliance with regulatory requirements and support the growth of our business.Key Responsibilities:Ensure store operations comply with MOH regulations.Develop and implement strategies for...
-
Regulatory Affairs Associate, Dubai
3 weeks ago
Dubai, Dubai, United Arab Emirates 3M Full timeRegulatory Affairs Associate (m/f/*)The Impact You'll Make in this RoleAs a Certification and Conformance Regulatory Affairs Associate for the 3M Personal Safety Division at 3M Gulf Ltd., you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.Here, you will make an impact...
-
Regulatory Affairs Manager
4 weeks ago
Dubai, Dubai, United Arab Emirates ClickJobs Full timeJobDescriptionTakeda DevelopmentCenter Americas, Inc. is seeking a Manager, Global RegulatoryAffairs CMC in Cambridge, MA with the following requirements:Master's degree in Regulatory Affairs or related fieldplus 2 years of related experience. Prior experience must include:Develop the regulatory submission strategies for products incommercial and development...
-
Regulatory Affairs Manager
2 weeks ago
Dubai, Dubai, United Arab Emirates ClickJobs Full timeJobDescriptionTakeda DevelopmentCenter Americas, Inc. is seeking a Manager, Global RegulatoryAffairs CMC in Cambridge, MA with the following requirements:Master's degree in Regulatory Affairs or related fieldplus 2 years of related experience. Prior experience must include:Develop the regulatory submission strategies for products incommercial and development...
-
Regulatory Affairs Specialist
5 days ago
Dubai, Dubai, United Arab Emirates ALFA GROUP Full timeWe are looking for an experienced Regulatory Affairs Specialist to oversee our compliance program.The ideal candidate will have expertise in policy development and implementation, risk management, and ethics and governance.Key Accountabilities:Identify, assess, and mitigate compliance-related risksServe as a resource for staff on compliance and ethical...
-
Regulatory Affairs Executive
2 days ago
Dubai, Dubai, United Arab Emirates PingPong Payments Full timePingPong Payments is a leading global payment company dedicated to empowering businesses with innovative cross-border payment solutions.Job SummaryWe are seeking a highly skilled Regulatory Affairs Executive to join our team in Abu Dhabi and Dubai to ensure full compliance with CBUAE regulations under the Retail Payment Service License and to support...
-
Regulatory Affairs Specialist
5 days ago
Dubai, Dubai, United Arab Emirates Client of Michael Page Full timeAbout the RoleThis is an exciting opportunity to join our Client of Michael Page as a Regulatory Affairs Specialist.The role involves analyzing and understanding wide-ranging issues affecting the industry and their implications.The successful candidate will communicate and negotiate professionally with a wide range of contacts.A thorough understanding of the...
-
Regulatory Affairs and Quality Specialist
3 days ago
Dubai, Dubai, United Arab Emirates Grifols, S.A Full timeSelect how often (in days) to receive an alert: Create Alert Regulatory Affairs and Quality Specialist Location: Dubai, SA Contract Type: Regular Full-Time Area: Quality Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company...
-
Regulatory Affairs and Quality Specialist
2 days ago
Dubai, Dubai, United Arab Emirates Grifols, S.A Full timeSelect how often (in days) to receive an alert: Create AlertRegulatory Affairs and Quality SpecialistLocation: Dubai, SAContract Type: Regular Full-TimeArea: QualityWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since...
-
Regulatory Affairs and Quality Specialist
4 hours ago
Dubai, Dubai, United Arab Emirates Grifols, S.A Full timeSelect how often (in days) to receive an alert: Create Alert Regulatory Affairs and Quality Specialist Location: Dubai, SA Contract Type: Regular Full-Time Area: Quality Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company...