Global Regulatory Intelligence Manager 1 Year FTC

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 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 Regulatory Intelligence Manager is responsible for proactively gathering, maintaining, and assessing critical regulatory intelligence pertinent to unlicensed (EAP, PTA, and PA-NPP), clinical trial, and commercial regulatory pathways. This role will ensure the organisation is well informed on the evolving regulatory landscapes, emerging trends, and potential impacts on WEP Clinical and its respective clients, as well as support in maintaining compliance with WEP Clinical’s Managed Access programmes.

The Ideal Candidate:

• Innovative
• Strategic
• Data driven
• Analytical
• Detail Oriented
• Problem Solver

Principal Duties and Responsibilities:

1. Regulatory Monitoring and Research:
   • Maintain WEP Regulatory Databases, ensuring that all country summaries are updated and periodically reviewed on time.
   • Conduct ad-hoc in-depth regulatory research for specific topics critical to project-related regulatory strategies.
   • Keep abreast of and subscribe to various regulatory databases, agency websites, industry publications, and expert networks.
   • Liaise with and be the main point of contact for vendor/outsourcing of regulatory intelligence-related work, ensuring that it is costed appropriately to relevant projects where applicable.
2. Regulatory Analysis and Interpretation:
   • Interpret regulatory information, identify key requirements and potential implications, and put information into summary documentation to assist WEP colleagues in project execution and strategic decisions.
   • Assess changes in regulatory intelligence and partner cross-functionally to identify critical opportunities and threats. Work with regulatory project leads to communicate impacts effectively.
3. Communication & Stakeholder Collaboration:
   • Communicate with regulatory agencies as needed to support the development of the regulatory database of country-specific information.
   • Present changes and impacts of new/upcoming regulatory information to WEP stakeholders.
   • Build relationships with key regulatory contacts (e.g., agencies, vendors) to provide added value and insights.
4. Process Development and Optimisation:
   • Strengthen the end-to-end regulatory intelligence processes within WEP Clinical to ensure robust and reliable gathering and analysis.
   • Identify areas for improvement and collaborate with stakeholders to develop solutions supporting compliance.

Qualifications:

• Bachelor\’s Degree (preferably in a health or science field)
• Minimum 4 years’ experience in Regulatory fields related to Clinical Trials and/or unlicensed supply management
• Ability to interpret legislation and assess regulatory requirements
• Effective research and summarisation skills
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment
• Strong verbal and written communication skills
• Ability to handle ambiguity, adopt flexibility, and structure amidst change
• Strong organisational skills and attention to detail
• Keen interest in process improvement
• Proficiency in Microsoft Office and computer literacy
• Highly self-motivated with strong interpersonal skills
• Discretion in handling confidential information

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
• Great social events

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. With over 15 years of experience distributing products across 120+ countries, we aim to treat unmet patient needs.

Our Commitment:

We foster wellness, growth, and team relationships through various initiatives. Check out our LinkedIn Life Page to learn more about our team events and employee support programs.

Our DEI Values:

Acceptance, recognition, and engagement are core to our DEI initiatives. We strive to provide opportunities for personal and professional growth, embracing everyone\’s unique identities.

Our Services Include:

• Expanded Access Programs (EAPs)
• Named Patient Programs (NPPs)
• Clinical Trial Supplies (Comparator & Ancillaries)
• Wren Nursing (Home Nursing & Education)
• Hospital Supply of Unlicensed Medicines

WEP Clinical is a smoke-free, drug-free, and alcohol-free environment. We are an equal-opportunity employer committed to non-discrimination and reasonable accommodations for disabilities.

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