Manager Regulatory Affairs Europe

Job content

Summary

The Manager, Regulatory Affairs is responsible for day-to-day coordination and preparation of regulatory submissions. The Manager will work and interact with internal cross-functional team members in order to create regulatory submission documents that are compliant with EU and/or global regulatory requirements and he/she will act as official liaison with European Regulatory Agencies for the assigned projects.

He/she supports planning and executing regulatory document preparation for regulatory submissions in Europe and in International geographies including CTAs, MAAs, Variations, Orphan applications, PIPs. He/she keeps abreast of evolving regulatory procedures and practices.

The Manager Will

Duties and Responsibilities

• Manage the creation, review, and submission of Scientific Advice, Orphan Drug Designations, pediatric plans, and MAA dossiers to optimize successful regulatory review and approval
• Manage the creation, review, and submission of CTA regulatory documents to support product development and clinical trials in Europe and rest of world as necessary.
• Provide regulatory guidance to departments and/or development project teams regarding the documentation and requirements for regulatory submissions.
• Collect reports and documentation and coordinate the content and format of submissions according to European health authority requirements.
• Create regulatory submissions from internal reports.
• Maintain current knowledge of relevant European and international guidance’s, laws and regulations, and proposed and final rules which affect pharmaceutical drug development and companion diagnostics.
• Ensure regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
• Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
• Ensure that dossiers containing quality, preclinical, and clinical data are presented clearly and succinctly to optimize the regulatory review and approval process.
• Ability to read and understand all components of a regulatory submission (CTA/MAA) to ensure consistency across documents.
• Coordinate the preparation of responses to questions and inquiries from Health Authorities. Prepare and submit CTA amendments and MA Renewal in accordance with regulatory submission schedules and regulations.
• Work with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and quality data in the required eCTD format
• Liaise with European health authorities as needed (e.g. telephone contacts, teleconferences, meetings, submissions).
• Ensure accurate retention in the archival system of all regulatory submissions and contacts with health authorities
• Coordinate and support regulatory activities with affiliates and consultants
• Contribute to improvements in department operating procedures
• Remain current with evolving regulatory procedures and practices, and provide guidance to Incyte project teams
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
  

Requirements

• BS degree, preferably in a scientific discipline with a minimum of 3 years regulatory experience and/or drug development experience.
• Experience in interactions with regulatory agencies. Experience with clinical trial applications
• Project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability
• Experience in orphan products
• Excellent communication skills; both oral and written.
• Demonstrated ability to contribute to a continuous learning and process improvement environment.
• Excellent analytical and organizational skills and ability to support multiple projects in a timeline-driven environment.
• Experience with document management systems, eCTD submissions managing, and maintaining regulatory files preferred.
  

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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