Job Ref. ID:
Regulatory Affairs Manager
UNITED ARAB EMIRATES
UAE (RAK head office)
Regulatory Affairs - Manager
Full Time Employment (Un-limited Contract)
Leads and manages merging activities issues where applicable, collaborate with other team leaders and assist in development of regulatory strategies to support the implementation of merging activities changes in line with regulatory registrations, working with business partners to effectively manage any stock outages. He will manage the implementation of registration strategies to expedite life-cycle optimization. Understands Country needs and works to improve the quality of the regulatory databases holding change requirements. Plays a key role in ensuring the development and implementation of effective and efficient project management process and contribute to achieve business objectives by driving the development of a regulatory strategy. Regulatory pricing assessment and impact on pricing strategy. Labeling strategy where common pack is supplied across regions. High quality dossier stretch goals on time of compilation / availability of change dossier to the countries. Develop and enhance relationships with key external stakeholders e.g. agencies (HA's / MoH distributors etc.) to understand and develop effective strategies.
Key responsibilities & Accountability:
Coordination with the Regulatory agents in foreign countries, distributor and other concerned departments in order to fulfill the registration requirements of Biotech products. Understanding and updating the latest product registration guideline and other regulatory aspects with the coordination of Country Manager / Agent. Supervise the preparation and timely submission of Biological & small molecules product registration dossiers as per the current guidelines of the respective countries as per management directives. Replying to the various queries raised scientifically and brigading product registration Review documents related to all the submissions and associated amendments and supplements including study reports, product labeling. Liaise with specialized individuals and sections within RA to meet submission requirements. Collaborate with PDL, QA, QC, Tender, Marketing and Accounts Departments in order to gather the relevant information required for submissions. Perform other related duties/additional tasks as required by management. Managing all parts of a regulatory project including overall strategy, resource, costs, time and clients. Assuming responsibility for a functional area or have a unique contribution to a department and choose the method and processes of work to achieve overall objectiveRelates / contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the Pharmaceutical portfolio at large. Leads document management and information management teams, within regulatory department. Training and coaching the team on soft skills and regulatory technical skills. Taking care the regulatory compliance issues within the Company. International correspondence with contract manufacturer for regulatory documents. Part of cross functional team to handle the API vendor selections and taking MOH approval of API source.
BS/B - Pharma degree (or higher) in a scientific field, preferably industry experience.
5-10 years' experience in regulatory affairs but business specifically.
AccountabilityAnalytical ThinkingBuilding TrustChange ManagementCommunicating in WritingCommunicating OrallyContinual ImprovementContinual LearningCustomer FocusDecision MakingDelegationDeveloping OthersEstablishing FocusFacilitationFlexibilityInnovationInterpersonal SkillsMaintaining Credibility/ Meeting Ethical StandardsManaging PerformanceProject ManagementSolving ProblemsSystems ThinkingValuing and Leveraging DiversityVisioning
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