CMC Project Manager<br><p>ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.</p><br><p>As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.</p><br><p>As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.</p><p></p><p><b>What You Will Do:</b></p><p></p><p>Your focus will be on overseeing regulatory affairs delivery, coaching your team, and driving continuous improvement.<br><br>Key responsibilities include:</p><ul><li>Participate in provision of regulatory expertise in strategic drug development across multiple areas.</li><li>Take part in preparation of strategic development and submission plans.</li><li>Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally).</li><li>Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities.</li><li>Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices</li></ul><p></p><p><b>Your Profile:</b></p><p></p><p>You will have a strong background in regulatory affairs, with proven management experience and a commitment to quality delivery.<br><br>Required qualifications and experience:</p><ul><li>Bachelor's degree in a relevant scientific discipline or healthcare-related field</li><li>EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience.</li><li>US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry.</li><li>Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.</li><li>Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail.</li><li>Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize.</li></ul><br><p>Employment with ICON is contingent upon having the legal right to work in the country where the role is based.</p><br><p><b>Rewards & Benefits</b></p><p>ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.</p><br><p>Benefits may include:</p><ul><li>Competitive base salary and performance related incentives</li><li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li><li>Retirement and pension plans</li><li>Life assurance and disability coverage</li><li>Employee assistance programmes and wellbeing resources</li><li>Learning and development opportunities through structured training and career pathways</li></ul><br><p>Benefits may vary depending on role and location.</p><br><p>Visit our <a href="https://careers.iconplc.com/benefits" target="_blank" rel="noopener noreferrer">careers site</a> to read more about the benefits ICON offers.</p><br><p><b>Inclusion and Accessibility</b></p><p>ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.</p><br><p>If you require reasonable accommodations during the recruitment process, please let us know or submit a request <a href="https://careers.iconplc.com/reasonable-accommodations" target="_blank" rel="noopener noreferrer"><span style="color:#0875e1"><b><u>here</u></b></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span>Are you a current ICON Employee? Please click </span><a href="https://wd3.myworkday.com/icon/d/task/1422$1235.htmld" target="_blank" rel="noopener noreferrer">here</a><span> to apply</span></p>