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:

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.
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. Working with regulatory Projects leads to accurately communicating the impact to projects.
Communication & Stakeholder Collaboration
Communicate with regulatory agencies as needed to support the development of the regulatory database of country-specific information.
Communicate and present changes and/or impacts of new/upcoming regulatory information to WEP stakeholders.
Build relationships with key regulatory contacts (e.g., agencies, vendors) to provide added value and regulatory insights.
Process Development and Optimisation
Strengthen the end-to-end regulatory Intelligence processes within WEP Clinical to ensure robust and reliable regulatory intelligence gathering and analysis.
Identify areas for improvement and work with key stakeholders to develop solutions that will support compliance within the business.
Qualifications:

Bachelor's Degree (in a health or science field preferred)
Minimum 4 years’ experience in Regulatory fields related to Clinical Trials and/ or unlicensed supply management
Ability to interpret legislation and assess regulatory requirements.
Ability to effectively research and summarise findings
Ability to manage multiple tasks and meet deadlines in a fast-paced environment
Strong verbal and written communication skills
Ability to manage ambiguity, adopt flexibility, and ascertain structure amidst this.
Strong organisational skills and attention to detail
Keen interest in process improvement.
Computer literacy and proficient in Microsoft Office
Highly self-motivated with strong interpersonal skills
Ability to handle confidential information with complete discretion
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 over 120 countries worldwide to treat 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 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 Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
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.

#J-18808-Ljbffr