Are you seeking an exciting and fulfilling new opportunity? 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 organisation dedicated to advancing clinical research and transforming lives.
Role Objectives
The WEP Clinical Global Regulatory Affairs Intelligence Associate is responsible for supporting the systematic collection, maintenance, analysis and communication of regulatory intelligence relevant to unlicensed access programmes, clinical development, commercial supply, and other regulated activities, where changes in regulation may impact WEP Clinical's operations, compliance obligations, or client programmes. The role contributes to ensuring WEP Clinical remains informed of evolving global regulatory requirements and emerging trends enabling complaint programme execution and informed regulatory decision making. The role operates under the direction of senior regulatory collects and support the maintenance of WEP Clinical's managed access and regulatory intelligence frameworks.
The Ideal Candidate
- Discrete
- Highly Organised
- Detail Oriented
- Strong Communicator
What You'll Do
- Maintain WEP Regulatory Databases, ensuring that all country summaries are up to date and periodically reviewed in a timely manner.
- Conduct structured regulatory research on defined topics to support project specific regulatory planning and programme execution.
- Monitor regulatory authority websites, subscribed intelligence platforms, and industry publications to identify relevant regulatory updates and emerging changes.
- Support the coordination of external regulatory intelligence vendors by tracking deliverables and ensuring outputs are shared appropriately with internal stakeholders.
- Review and interpret regulatory information to identify key requirements and considerations, summarising findings in clear, structured documentation for use by regulatory and cross functional teams.
- Identify potential regulatory changes, risks, or uncertainties and escalate findings to regulatory project leads or managers for further assessment and decision making.
- Support communication with regulatory authorities, where appropriate and under supervision, to clarify or validate country specific regulatory information.
- Support cross functional discussions by providing regulatory intelligence inputs relevant to project delivery, compliance obligations, and programme design.
- Identify opportunities for improved efficiency, consistency, or clarity in regulatory intelligence activities and propose improvements to senior team members.
What You'll Need
- Bachelor's degree required, preferably in a health or science related field
- 1-2 years of experience in a regulated healthcare environment such as a CRO, biotechnology, pharmaceutical, or similar regulated organization
- Foundational understanding of regulatory pathways across the product lifecycle, including clinical development, early access, and commercial supply
- Exposure to global regulatory frameworks including EU/UK, US FDA, and other international markets
- Ability to interpret regulatory guidance, legislation, and authority communications and distill key requirements and implications
- Experience supporting regulatory intelligence tools, databases, or structured regulatory trackers
- Strong research, analytical, and summarisation skills with high attention to detail
- Proven ability to manage multiple priorities, meet deadlines, and work effectively in a fast paced, ambiguous environment
- Excellent written and verbal communication skills with strong organisational abilities and discretion in handling confidential information
- Proficient in Microsoft Office, highly self motivated, collaborative, and driven toward continuous process improvement
What We Offer
- Private healthcare insurance
- Long term illness Cover
- Death in service cover
- Salary sacrifice pension
- Annual leave
- Paid maternity & paternity leave
- Volunteer day
What 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 more than 120 countries worldwide, addressing unmet patient needs.
We're Committed to Our Team
WEP has many initiatives to encourage wellness, growth, 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 values of our DEI. We are committed to providing employees with opportunities for personal and professional growth and success, embracing everyone's unique identities.
Our services include
- Access Programs
- Clinical Trial Services
- Patient Site Solutions
- Clinical Trial Supply
- Market Access and Commercialisation
WEP 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.