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Regulatory Affairs Manager
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We are seeking a highly skilled Regulatory Affairs Manager to join our team at Precision Medicine Group. As a key member of our regulatory team, you will be responsible for providing regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures.
Key Responsibilities- Develop and implement regulatory strategies to ensure compliance with applicable regulations and guidelines.
- Provide regulatory guidance throughout the clinical development life cycle, including clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities.
- Compile, coordinate, and review applications to Regulatory Authorities, including INDs/CTAs, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.
- Develop and/or review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
- Serve as a representative of Global Regulatory Affairs at project team meetings with both external and internal customers.
- Work within a project team, and where necessary, lead project for the region or globally.
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.
- Maintain project plans, project trackers, and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Assist in the development of Regulatory Affairs Specialists and other operational area staff, as required.
- Provide input, as required, into regulatory strategy and timeline development for new study opportunities.
- Assist in establishing company standards to ensure the highest quality of submitted information.
- Participate in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
- Stay up-to-date with laws, regulations, and guidelines governing drug development and approval.
- Provide ICH GCP guidance, advice, and training to internal and external clients.
- Serve as a representative of Global Regulatory Affairs at business development meetings.
- Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
- 5 years of regulatory experience required for the Manager level and 7 years of regulatory experience required for the Senior Manager Regulatory level.
- Computer literacy (MS Office/Office 365).
- Fluent in English.
- Regulatory affairs experience working for a Clinical Research Organisation and experience leading Clinical Submissions.
- Informed knowledge of all aspects of the drug development process, including regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US).
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy.
- Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.
- Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.
- Availability for domestic and international travel, including overnight stays.
- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities.
- Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture, and positive interactions with customers and teammates.
- Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills.
- Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment.
- Motivates other members of the project team to meet timelines and project goals.
- Flexible attitude with respect to work assignments, and new learning.
- Resolves project-related problems and prioritizes workload to meet deadlines with little support from management.
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
- Collects data of consistently high standard.
- Communicates effectively in the English language both verbally and in written form.
- Conducts formal presentations to a wide variety of audiences, including colleagues, investigative staff, and clients, with a high level of proficiency.
