Description
<p>About Freyr</p><p>Freyr Inc. is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a dynamic, innovative, and collaborative environment. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries.</p><p>At Freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. Join a company that values innovation, integrity, and the power of collaboration.</p><p><br></p><p>Why Join Freyr:</p><p>Be part of a global, fast-growing organization that operates in over 150 countries.</p><p>Opportunity to work on impactful projects in a dynamic and innovative environment.</p><p>Competitive salary and benefits package, including performance-based incentives.</p><p>Flexible work options to support work-life balance.</p><p>Continuous learning and professional development opportunities.</p><p>Collaborative and inclusive work culture that values diversity.</p><p><br></p><p><b>Lead Regulatory Project Manager</b></p><p><b>Location: Remote</b></p><p><b>Job Type: Permanent/FTE</b></p><p><br></p><p><b>Position Overview:</b></p><p><b>Key Responsibilities</b></p><p>Partner with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for high-complexity programs/products are established and executed seamlessly.</p><p>Expertly lead cross-functional project submission working groups (SWGs) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for complex, novel, and critical programs.</p><p>Provide expert project management leadership, oversight, direction, and planning.</p><p>Directly support the program GRL by ensuring project management and regulatory operational support for the asset.</p><p>Perform regulatory operational activities and oversee vendors providing operational support for assigned programs.</p><p>Provide additional support as required.</p><p><br></p><p><b>Minimum Requirements</b></p><p><b>Education:</b></p><p>Bachelor’s or Master’s degree in Pharma/Medical or another associated scientific discipline OR equivalent.</p><p><br></p><p><b>Experience:</b></p><p>Minimum 8 years in the <b>Regulatory field</b> and 5 years of demonstrated <b>project management</b> skill sets.</p><p>Expertise with project management software and tools, e.g., MS Project, SharePoint, OneNote. Additional experience with OnePager and Office Timeline preferred.</p><p>Proven experience driving submissions for major markets (e.g., US IND, NDA, BLA, EU MAA, EU variations).</p><p>At least one major (original or supplement) and several minor (amendment) filing experience in one or more jurisdictions.</p><p>Experience with eCTD and submission timeline management is required.</p><p><br></p><p><b>Skills:</b></p><p>Strong conceptual and analytical thinking skills.</p><p>Deep understanding of global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology, and process.</p><p>Proficiency in MS Office (Word, Excel, Outlook).</p><p>Ability to multitask, prioritize competing assignments, and work under deadlines in a fast-paced environment.</p><p>Excellent verbal and written communication skills; ability to prepare effective presentations with focused messaging.</p><p>Demonstrates strong collaboration and interpersonal skills with the ability to work across departments and external organizations.</p><p>Fluency in English (written, verbal, reading).</p><p><br></p><p><b>What We Offer:</b></p><p>Competitive salary and benefits package.</p><p>Flexible work environment (remote or hybrid options available).</p><p>Opportunity to work with a global team and contribute to impactful projects.</p><p>Continuous professional growth through training and development programs.</p><p>Inclusive, collaborative, and innovative work culture.</p>
