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A leading company in the healthcare sector is seeking a Mid-Senior level professional to manage product submissions and ensure compliance with regulatory standards. The role involves overseeing the lifecycle of products and mentoring junior staff while adapting to changing priorities. Ideal candidates will possess strong communication and organizational skills, with a focus on quality deliverables.
• Authoring and reviewing documents for post-approval changes and line extensions.
• Handling post-approval changes, assigning proper categories to particular changes based on regulatory guidelines.
• Escalating, notifying, and resolving issues that may impact final submissions.
• Managing the end-to-end lifecycle of products registered in the Turkey market.
• Maintaining internal trackers for post-approval changes and line extension submissions as per anniversaries.
Qualifications we seek in you!
Minimum Qualifications / Skills
Preferred Qualifications / Skills
• Ensuring adherence to project specifications or standards throughout the submission lifecycle.
• Effective time management and organizational skills to handle multiple time-sensitive assignments.
• Deep understanding of the business value of quality and compliance, and the risks of non-compliance, with behaviors adjusted to ensure high-quality deliverables.
• Ability to independently troubleshoot problems within responsibilities and consider new perspectives using existing solutions.
• Effective verbal and written communication skills to build alignment around complex issues and processes.
• Flexibility to adapt to changing environments and stay current with new processes and procedures.
• Depending on experience, mentoring new staff or leading a team of junior staff.
• Flexibility in responding to changing priorities or unexpected events.
• Capability to handle multiple priorities and balance work to meet business goals.
Additional Information: