Product Compliance Manager
Vor 6 Tagen
About the Role
This is an exciting opportunity to join our team as a Regulatory Affairs Specialist. You will play a key role in ensuring the success of our product launch in the biotechnology market. The position requires a high level of expertise in regulatory affairs and excellent communication skills.
Your Key Responsibilities:
- Prepare and compile regulatory documentation for submission to authorities like FDA, European Notified Bodies, Health Canada, etc.
- Review analytical data from development and performance evaluation studies.
- Provide guidance to staff and project teams on data and information required for successful license applications.
- Develop regulatory requirements for product labelling and liaise with internal and external parties.
- Maintain knowledge of new or updated regulatory requirements and industry standards.
- Ensure maintenance of product regulatory documents and technical files to support compliance.
- Liaise with regulatory authorities and external contract bodies.
- Participate in product development projects to provide regulatory guidance.
- Document changes in accordance with quality system requirements and communicate them to regulatory authorities.
- Provide support, guidance, and training to team members.
- Perform other duties as requested and ensure compliance with GMP, GDP, and other regulatory requirements.
Your Profile:
- Relevant degree and/or work experience in a regulatory affairs environment.
- Previous regulatory experience, knowledge of CE and FDA regulations, and experience in preparing and submitting regulatory documents.
- Ability to prepare regulatory reports, sound knowledge of IT packages, and experience with regulatory submissions.
- Team player with clear communication skills.
- Proactive and able to work independently or within a team.
- Attention to detail and ability to analyze information.
- Ability to work under pressure and manage workload effectively.
- Leadership skills and ability to build relationships with stakeholders.
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