About Us
We are a forward-thinking organization that thrives on innovation and teamwork. Our company culture is built on the principles of collaboration, creativity, and a passion for excellence. As a Regulatory Intelligence Specialist, you will join a vibrant community of professionals who share your commitment to driving success and making a meaningful impact in the industry.
Job Summary
We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team. As a Regulatory Intelligence Specialist, you will play a crucial role in ensuring that our organization stays up-to-date with regulatory updates and implements relevant requirements. You will collaborate closely with stakeholders, contribute to the continuous improvement of our Quality Management System (QMS), and maintain our compliance standards.
Key Responsibilities
- Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
- Act as the point person for regulatory intelligence-related consultancy, providing expert guidance and support to internal stakeholders.
- Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections, as needed and relevant to Regulatory Intelligence Activities.
- Maintain the Regulatory Intelligence SharePoint and filing areas, ensuring accurate and up-to-date information is readily available.
- Provide technical knowledge and expertise where appropriate, supporting the development of quality/process documents, tools, and templates.
- Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.
- Generate metrics on Regulatory Intelligence Activities, providing valuable insights to Senior Management.
- Contribute to the metrics provided to Senior Management, ensuring that our organization's compliance and quality standards are met.
- Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.
- Undertake other duties as assigned, demonstrating flexibility and a commitment to excellence in all aspects of the role.
Skills and Experience Required for the Role
To succeed as a Regulatory Intelligence Specialist, you will need to possess a unique blend of skills and experience. We are looking for individuals who are passionate about regulatory affairs, quality management, and compliance. If you have a strong background in one or more of the following areas, we encourage you to apply:
- Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
- Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
- Good understanding of regulatory affairs landscape, including knowledge of relevant regulations and guidelines.
- Experience working with clinical trials, including knowledge of trial design, conduct, and management.
- Project management capabilities applicable to Regulatory Intelligence activities and oversight.
- Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
- Ability to rapidly learn, understand, and apply applicable corporate procedures.
- Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm.
- Ability to lead projects and teams, demonstrating leadership and collaboration skills.
- Strong ability to analyze and interpret data, providing valuable insights to inform business decisions.
- Attention to detail and advanced organizational skills, ensuring accuracy and efficiency in all aspects of the role.
- IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis or Tarius.
- Proficiency in written and oral English, with the ability to communicate effectively with internal and external stakeholders.
Career Growth Opportunities and Learning Benefits
We are committed to the growth and development of our employees. As a Regulatory Intelligence Specialist, you will have access to a range of learning and development opportunities, including:
- Regular training and development programs, designed to enhance your skills and knowledge in regulatory affairs, quality management, and compliance.
- Mentorship and coaching, providing guidance and support to help you achieve your career goals.
- Opportunities for career advancement, including promotions and new roles within the organization.
- Access to industry-leading tools and technologies, including Regulatory Intelligence applications such as Cortellis or Tarius.
- A collaborative and supportive work environment, where you can share your ideas and expertise with colleagues from diverse backgrounds and disciplines.
Work Environment and Company Culture
We are a remote-friendly organization, offering flexible work arrangements that allow you to work from anywhere. Our company culture is built on the principles of collaboration, creativity, and a passion for excellence. We value diversity, equity, and inclusion, and are committed to creating a workplace that is welcoming and inclusive for all employees.
Compensation, Perks, and Benefits
We offer a competitive salary and a range of benefits, including:
- A competitive salary, commensurate with experience and qualifications.
- A comprehensive benefits package, including health insurance, retirement savings, and paid time off.
- A flexible work arrangement, allowing you to work from anywhere.
- A range of perks and benefits, including access to industry-leading tools and technologies, regular training and development programs, and opportunities for career advancement.
How to Apply
If you are a motivated and detail-oriented Regulatory Intelligence Specialist with a passion for regulatory affairs, quality management, and compliance, we encourage you to apply. Please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you!
We Want to Hear From You!
Don't hesitate to apply today and let's build the future together. We are excited to hear from you and learn more about your qualifications and experience.
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