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.
Desired candidate profile
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.
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