This is a full-time role for a Regulatory Affairs Manager. The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining quality systems. The position will be:
- Acting as primary contact point for regulatory matters within Europe
- Ensuring compliance with relevant laws, regulations, and guidelines related to clinical research activities.
- Developing and implementing policies and procedures to ensure regulatory compliance.
- Providing regulatory guidance and support to project teams, including reviewing study protocols, informed consent forms, and regulatory submissions.
- Managing regulatory submissions via CTIS to regulatory authorities, clinical trial applications, and amendments.
- Communicating with regulatory agencies as needed to obtain approvals and address any regulatory issues that arise.
- Keeping abreast of new and changing regulations and guidelines and ensuring that the organization remains compliant.
- Providing regulatory training to staff members and ensuring that they are knowledgeable about regulatory requirements.
- Collaborating with internal and external stakeholders, such as sponsors, investigators, and regulatory agencies, to address regulatory concerns and ensure successful study conduct.
- Leading regulatory inspections and audits, and implementing corrective actions as needed.
- Maintaining documentation of regulatory activities and ensuring that all regulatory documents are filed appropriately
Qualifications
- Regulatory Compliance and Regulatory Affairs skills
- Understanding of Regulatory Requirements
- Experience in managing Regulatory Submissions
- Knowledge of Quality System management
- Strong analytical and problem-solving skills
- Excellent attention to detail and organizational skills
- Effective communication skills and ability to work in a team
- Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, or related field