License Compliance Intern at Boomi helping customers comply with license agreements. Analyzing business data and supporting compliance audits in a dynamic work environment.
About the role
- Regulatory Affairs Franchise Leader driving global regulatory strategy across APAC, MEA, Eastern Europe, and LATAM for Pierre Fabre's pharmaceutical products.
Responsibilities
- Develop a holistic vision for franchise internationalization, including lifecycle management and new market opportunities
- Anticipate, analyse and propose regulatory strategies for product registrations and maintenance across markets
- Coordinate the evaluation, implementation and planning of regulatory strategies with relevant stakeholders
- Ensure that international regulatory requirements and impacts are integrated into the overall global product regulatory strategy
- Provide strategic and operational support to local RA contacts (internal affiliates or external partners)
- Ensure effective implementation of the global internationalization strategy and registration plans at local level
- Build and maintain close relationships with key local regulatory contacts
- In collaboration with RA project Managers and other stakeholders, coordinate: Alignment and arbitration of priorities, in line with WRA and Franchise objectives
- Planning and tracking of regulatory activities
- Oversight of regulatory compliance and coordination of associated action plans
- Provide operational back-up to RA project managers when needed, and be able to temporarily cover critical activities if required
- Act as a Regional Champion, as assigned by the Head of International deployment, contributing to cross-product or transversal activities
- Analyse and share the impact of new or evolving regulations
- Assess associated risks
- Propose adjustments to the internationalization strategy when needed
- Contribute to the development and optimisation of Regulatory Affairs processes (SOPs, best practices, tools, knowledge sharing, etc.)
- Actively participate in department meetings, contributing to agenda topics and decision-making
- Help onboard and train new team members in your areas of expertise, in line with onboarding plans set by management
- Contribute to enhancing visibility and understanding of Regulatory Affairs within the company
Requirements
- University degree in Pharmacy, Life Sciences or equivalent
- Significant experience (typically 7–10+ years) in Regulatory Affairs within the pharmaceutical industry
- Proven track record in international markets (emerging markets, APAC, LATAM, Middle East/Africa)
- Experience in leading regulatory strategy for a product portfolio or franchise
- Strong knowledge of global regulatory frameworks and requirements for medicinal products
- Demonstrated ability to define and execute regulatory strategies across multiple countries/regions
- Fluent English (spoken and written); additional languages are an asset.
Benefits
- Incentives
- profit-sharing
- Pierre Fabre shareholding with matching contribution
- health and provident insurance
- 16 days of holidays (RTT) in addition to 25 days of personal holidays
- public transport participation
- very attractive CE
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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