REGULATORY AFFAIRS LEAD

Job OverviewPosition: Senior Regulatory Affairs LeaderLocation: Remote (Anywhere in Spain) Or EUContract Type: Contract or PermanentLevel: Mid - SeniorSalary: NegotiableJoin our dynamic, remote-first team as a Senior Regulatory Affairs Leader. Reporting directly to the Project Director, Director of Project Management, or their designee, you will lead our regulatory activities with a strong focus on collaboration and leadership.We can look at candidates in the EU also.Key Responsibilities:Develop and execute regulatory submission strategies in line with client requirements and project timelines.Lead the regulatory and start-up teams in preparing, submitting, and ensuring quality checks for regulatory documents, including initial submissions, amendments, and responses.Implement quality control processes to ensure regulatory documentation meets high standards before client delivery and submission.Guide regulatory team discussions, identify risks, and design effective mitigation strategies.Maintain and track regulatory documentation to comply with guidelines and client requirements.Develop and uphold regulatory standard operating procedures (SOPs).Monitor and analyze regulatory changes and trends, providing insights to shape regulatory strategies.Train internal teams or clients on regulatory activities as needed.Assist in meetings with regulatory agencies and help resolve regulatory queries.Supervise and mentor regulatory affairs professionals, fostering their growth.Support proposal preparation, study budgets, timelines, and service agreements.Qualifications and Experience:Bachelor’s or Master’s degree in Life Sciences or a related field.10+ years of experience in regulatory affairs, with a proven track record in clinical trial submissions.Experience with FDA submissions and Clinical Trials Information System (CTIS) is essential.Familiarity with Investigational New Drug (IND) applications is a plus.Strong understanding of regulatory procedures for clinical trials and cross-functional dependencies.Excellent organizational skills, with the ability to manage multiple tasks and ensure document accuracy.Effective communicator, skilled in working with internal teams and regulatory bodies.Experience in therapeutic areas such as CNS/Neurology, Oncology, Cardiovascular, and Rare Disease is advantageous.Experience in business development within a CRO environment is a plus.Proficiency in Microsoft Office and other relevant software applications.About Us:We are a forward-thinking CRO with a global reach, providing comprehensive clinical development and resource solutions. Serving emerging biotech and pharmaceutical companies, we operate in key markets including the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.As part of the J.K. Organisation, a multinational conglomerate with a 125-year legacy and $4 billion USD in annual revenues, we offer a solid foundation and the support to focus on what truly matters.Interested? Submit your updated CV and expected rate for an informal discussion today!Stability and Scale: With over 40,000 employees across 60 countries, our partnership with the J.K. Organisation ensures stability and a robust operational foundation. Join us in shaping the future of clinical research!