Regulatory Affairs Manager

hace 2 días

Madrid, España Intelstack A tiempo completo

Job Title: Contractor Local Regulatory Affairs ManagerLocation: SpainJob Type: Contract RoleDuration: 11 MonthsJob DescriptionWe are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Spain market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and line extensions for cardiovascular products. A strong understanding of ICH guidelines and local regulatory requirements in Spain is essential.ResponsibilitiesDocument Management: Author and review documents related to post-approval changes and line extensions, ensuring compliance with regulatory standards.Change Handling: Manage post-approval changes by assigning appropriate categories based on regulatory guidelines, ensuring all changes are documented and compliant.Issue Resolution: Escalate, notify, and resolve any issues that may impact final submissions to regulatory authorities.Lifecycle Management: Take end-to-end responsibility for the lifecycle management of products registered in the Spain market, ensuring all regulatory requirements are met throughout the product's life.Internal Tracking: Maintain an internal tracker for post-approval changes and line extension submissions, ensuring timely updates as per anniversary requirements.Regulatory Strategy Development: Design regulatory strategies and make decisions regarding Chemistry, Manufacturing, and Controls (CMC) filings to support product registration and compliance.Qualifications We SeekMinimum Qualifications / SkillsBachelor’s Degree in Pharmacy (B. Pharmacy) or Master’s Degree in Pharmacy (M. Pharmacy).Preferred Qualifications / SkillsEnsure adherence to specific project specifications or standards throughout the submission lifecycle.Demonstrate effective time management and organizational skills to manage multiple time-sensitive assignments.Understand the business value of quality and compliance, adjusting behaviors to drive high-quality deliverables.Solve problems independently, utilizing existing solutions from a new perspective.Communicate complex issues effectively both verbally and in writing to build alignment among stakeholders.Adapt to changing environments while staying current with new processes and procedures.Depending on experience level, mentor newly hired staff or lead a team of junior staff.Flexibility in responding to changing priorities or unexpected events while balancing multiple tasks to achieve business goals.Need to know Spanish language and Spain regulations

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