Senior Regulatory Affairs Officer/Lead

<h3>Company Description</h3><p>We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals.  We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.  </p><p>Learn more why you should join PSI <a href="https://psi-cro.turtl.co/story/psi-career-facts-and-figures/page/1">here</a>!</p><h3>Job Description</h3><p>Join our team of experts in a role that provides global exposure to clinical trials regulatory management.</p><p><strong>In this role you will:</strong></p><ul><li>Act as a study Regulatory Lead for multi-country studies</li><li>Develop country-specific and global study submission strategies, plan study regulatory timelines</li><li>Be a point of contact for clients on all study regulatory aspects</li><li>Participate in client meetings (kick-off meetings, bid defense meetings) </li><li>Communicate with regulatory authorities, ethics committees, project teams on regulatory-related matters</li><li>Be on top of changes/amendments to legislative acts pertaining to clinical trials in PSI countries</li></ul><p><u>Hybrid work with the office in Warsaw.</u></p><h3>Qualifications</h3><ul><li>College/University degree in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training, and experience</li><li>Minimum 3 years of solid experience with clinical trial regulatory and ethics submissions</li><li>Experience with acting as a global Regulatory Lead on multi-country trials is a plus</li><li>Full working proficiency in English and Polish; and in MS Office applications</li><li>Ability to learn, plan and work in a dynamic team environment</li></ul><h3>Additional Information</h3><p>What we offer:</p><ul><li>We'll prepare you to do your job at highest quality level with our extensive onboarding </li><li>You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together </li><li>You'll have permanent work agreement at a stable, privately owned company</li><li>We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card </li><li>We're constantly growing which means opportunities for personal and professional growth </li></ul><p>Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.<br/> <br/> <strong>Please provide your CV in English. </strong></p><p><strong>If you have any questions, don't hesitate to reach out to the recruiter at </strong><a href="mailto:patrycja.kal@psi-cro.com">patrycja.kal@psi-cro.com</a><strong> or on </strong><a href="https://www.linkedin.com/in/patrycjakal">linkedin.com/in/patrycjakal</a></p>