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Senior Regulatory Affairs Manager
hace 2 meses
We are seeking a highly experienced and skilled Senior Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing regulatory activities across various regions, ensuring compliance with applicable regulations and good clinical practices.
Key Responsibilities- Regulatory Leadership: Provide strategic guidance and oversight to ensure the successful execution of regulatory activities, including the preparation and submission of clinical trial applications and IRB/IEC packages.
- Team Management: Lead and manage a team of regulatory professionals, providing coaching, mentoring, and performance management to ensure high-quality deliverables.
- Regulatory Intelligence: Stay up-to-date with evolving regulatory requirements and guidelines, providing guidance and support to the team on compliance and regulatory matters.
- Process Improvement: Identify areas for process improvement and implement changes to enhance efficiency and effectiveness in regulatory operations.
- Client Relationships: Develop and maintain strong relationships with clients, stakeholders, and regulatory authorities to ensure effective communication and issue resolution.
- Education: Bachelor's degree (or equivalent) in life sciences or a scientific discipline.
- Experience: At least 8 years of experience in clinical regulatory affairs, including 3 years in a management role, with a strong background in preparing, reviewing, and submitting clinical trial applications and IRB/IEC packages.
- Skills: Solid knowledge of review and approval processes of applicable regulatory health authorities, excellent communication and interpersonal skills, and the ability to assess impact and provide guidance.
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We are committed to providing high-quality research and services that exceed our clients' expectations. Our values include collaboration, innovation, reliability, and responsiveness, and we offer a stimulating work environment and attractive advancement opportunities.
