WEP Clinical · 11 hours ago
Sr. Regulatory Affairs Associate
United States
Full-time
Remote
Mid, Senior Level
3+ years expWEP Clinical is a mission-driven organization dedicated to advancing clinical research and transforming lives. The Sr. Regulatory Affairs Associate will play a pivotal role in developing and executing regulatory strategies to ensure timely access to medicines for patients with urgent unmet medical needs.
BiotechnologyInformation TechnologyPharmaceutical
Responsibilities
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
Qualification
Required
3+ years of broad regulatory experience
Familiarity with global regulatory frameworks, in particular EU and FDA regulations
Experience in developing regulatory strategies
Ability to communicate within a project setting either to clients or internal key stakeholders, effectively articulate project related matters, risks or updates
Strong analytical skills to practically and pragmatically apply regulatory intelligence and to map it onto projects, identifying the critical path, timelines, risks and propose solutions
Proven ability to handle multiple projects and priorities in a fast-paced environment
Strong problem-solving abilities, being proactive and solution oriented
Strong organizational skills and attention to detail
Computer literacy and proficient in Microsoft Office
Ability to handle confidential information with complete discretion
Preferred
Bachelor's degree (legal, life sciences, or scientific equivalent preferred)
Understanding and expertise of unlicensed supply (e.g. Expanded Access, Compassionate Use, Named Patient) preferred
Benefits
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
Company
WEP Clinical
WEP Clinical is a specialist pharma services company that works with drug developers.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
TJC
2021-11-17Private Equity
Leadership Team
Robert Goodman
Chief Commercial Officer (CCO)
Recent News
2026-01-12
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