Regulatory Affairs Manager (m/f/d)

at  Palleos healthcare GmbH

REGULATORY AFFAIRS MANAGER (M/F/D)

palleos healthcare is an international full-service CRO focused on Central and Eastern Europe. We offer clients in the pharmaceutical industry and biotech companies a wide range of services with a high level of medical expertise. Our expertise ranges from conducting clinical trials to advising on development plans and the market launch of innovative medical products and drugs.

ROLE DESCRIPTION

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.

KEY RESPONSIBILITIES:

• 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.

THIS ROLE DEMANDS:

• 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