Regulatory Affairs Specialist

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.Role Objectives:The WEP Clinical Regulatory Affairs Manager plays a pivotal role in developing, executing and supporting the regulatory strategy with respect to the various projects managed by WEP Clinical (primarily Post-Approval Named Patient Programs, Expanded Access Programs, Compassionate Use Programs, and Clinical Trials). The Regulatory Affairs Manager will be responsible for managing regulatory submissions, ensuring compliance, and providing expert regulatory guidance to enable timely access to medicines for patients with urgent unmet medical needs across various global markets. The Regulatory Affairs Manager will be a key contributor to WEP Clinical projects, working closely with cross-functional teams to navigate complex and unique regulatory pathways. The Ideal Candidate:A Team Player Communicative A Self StarterIndependent WorkerWhat You'll Do:Serve as the primary Regulatory Affairs contact for Clinical Trial, EAP, CUP, and PA-NPP activities across the US, Europe, and ROW, providing strategic and pragmatic guidance to colleagues and clients.Develop and implement robust regulatory strategies to ensure timely, compliant access to products in accordance with destination country requirements.Provide regulatory guidance and support to clinical sites to facilitate product supply.Maintain accurate, up-to-date regulatory documentation, databases, and project records.Manage regulatory changes impacting projects, clearly communicating implications and ensuring completion of critical actions to prevent disruptions.Participate in project kick-off and maintenance meetings, delivering updates and addressing regulatory-related queries.Support Business Development through input on proposals, budgets, and client bid defenses.Oversee domestic licenses (US, UK, IE) in collaboration with Quality and Supply Chain, managing variations and submissions to Health Authorities as needed.Lead the preparation, compilation, and submission of regulatory applications (e.g., CUP/EAP/CT) to authorities such as MHRA, ANSM, and FDA, ensuring quality and timeliness.Coordinate with cross-functional teams (Medical Affairs, Quality, Supply Chain, PM) to gather documentation, manage Health Authority inquiries, and proactively mitigate risks.Build and maintain strong relationships with Health Authorities, clients, and industry associations, contributing regulatory expertise to cross-functional and client meetings.Support team management, training, SOP and policy development, and lead continuous improvement initiatives to enhance compliance and efficiency within Regulatory Affairs.What You'll Need:Bachelor's degree (legal, life sciences, or scientific equivalent preferred) 3+ years of broad regulatory experience Familiarity with global regulatory frameworks, in particular EU and FDA regulations Understanding and expertise of unlicensed supply (e.g. Expanded Access, Compassionate Use, Named Patient) preferred. Experience in developing regulatory strategiesAbility to communicate within a project setting either to clients or internal key stakeholders, effectively articulate project related matters, risks or updatesStrong analytical skills to practically and pragmatically apply regulatory intelligence and to map it onto projects, identifying the critical path, timelines, risks and propose solutionsProven ability to handle multiple projects and priorities in a fast-paced environmentStrong problem-solving abilities, being proactive and solution orientedStrong organizational skills and attention to detailComputer literacy and proficient in Microsoft OfficeAbility to handle confidential information with complete discretionWhat We Offer:Medical, dental, and vision insurance, FSA, HSAVoluntary short-term and long-term disability insuranceVoluntary life insurance401K safe harbor plan and company matchPaid vacation, holiday, and sick timePaid maternity & paternity leaveWhat sets us apart:WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.We're Committed to Our Team:WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.We're Committed to DEI:At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.Our services include:Access Programs Clinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket Access and CommercializationWEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.