Global Data and Documents Regulatory Operations Specialist
Global Data and Documents Regulatory Operations Specialist (x2)Are you ready to take your regulatory expertise to the next level? Our client is seeking a dynamic and detail-oriented Global Data and Documents Regulatory Operations Specialist to join their innovative team. This exciting opportunity is offered as a hybrid position, with three days onsite, blending flexibility with collaboration.Contract Duration: 1 position is for 1 year and the other is for 6 monthsLocation: Hybrid - 3 Days OnsiteWhat You''ll Do:As a pivotal member of our cross-functional product development teams, you will play a crucial role in ensuring compliance with applicable regulations and standards. Your responsibilities will include:Regulatory Guidance: Participate in and advise teams on regulatory requirements for new products and solutions.Submission Coordination: Plan, generate, and coordinate regulatory submissions, ensuring all necessary information is included.Testing Coordination: Oversee testing processes that support regulatory submissions.Labelling Review: Review and approve product labelling and marketing communications to ensure compliance.Maintenance of Filings: Maintain existing regulatory filings and licences while managing updates and change control processes.Strategic Advisement: Advise product design teams on regulatory strategy based on market trends and competitive landscape.Planning andamp; Compliance: Develop regulatory plans for new product introductions and changes, ensuring ..... full job details .....
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