Regulatory Affairs Specialist

Job SummaryWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Antal Sp. z.o.o. The successful candidate will be responsible for compiling regulatory documentation, ensuring quality targets are met, and performing technical quality control of dossier documents and complex submissions.Key ResponsibilitiesAct as the first-level...

Previous experience in electronic submission publishing, dossier management, and the dispatch of regulatory dossiers across various regions. Demonstrated experience in publishing complex and major submissions, including modules 3, 4, and 5. Strong knowledge of global regulatory processes within the pharmaceutical industry and submission publishing...

Key Responsibilities:Lead audit processes to ensure compliance with regulatory requirements.Implement Identity and Access Management (IIQ) and Single Sign-On (SSO) solutions.Develop and maintain IT risk registers and vulnerability management plans.Collaborate with IT and application teams to resolve security and compliance issues.Stay up-to-date with...

Key Responsibilities: Handle audits and ensure compliance with regulatory requirements.Key Skills: Strong IT knowledge and risk management skills.Requirements: Audit experience.Additional Benefits: Sport subscription. Private healthcare. International projects.

Strong understanding of AWS services and architecture principles. Hands-on experience designing and implementing cloud solutions on AWS. Knowledge in API design, implementation and system integration using APIs. Experience working with industry-standard integration frameworks and patterns. Knowledge of networking, security, and storage concepts, REST API,...

Key Responsibilities:Manage and mitigate IT risks to ensure compliance with regulatory requirements.Implement and maintain IT security controls, including IIQ and SSO.Collaborate with IT and application teams to identify and resolve vulnerabilities.Develop and document IT risk management strategies.Requirements:Strong IT knowledge and risk management...

Auditing, Compliance, and Risk Management ExpertiseDevelop and implement robust audit processes to ensure compliance with regulatory requirements.Collaborate with IT and application responsible teams to identify and mitigate IT vulnerabilities.Design and implement effective security and compliance strategies.Additional Responsibilities:Manage IT risks and...

A key role at AVENGA involves ensuring the company's IT systems and processes are aligned with regulatory requirements. The ideal candidate will have a strong understanding of IT risk management and compliance principles. Key responsibilities include:Audit and Compliance: Handle audit processes to identify and mitigate risks.Security and Compliance...

Have strong business and technical background and great data analytical skills Have good requirement specification skills Have ability to work both independently and as a part of a team Are familiar with agile ways of working and methods Are proactive, structured, detail-oriented and quality driven ✔️ Your experience and background: Have good...