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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in European regulatory affairs, including the management of marketing authorizations and compliance with local requirements. Proficient in coordinating complex projects and collaborating with cross-functional teams to ensure successful regulatory outcomes.
Highest-signal resume keywords
Regulatory Affairs ExpertiseEuropean Marketing AuthorizationsRIM ProficiencyFluency in English and FrenchMaster’s Degree in Regulatory Affairs
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Strategy ImplementationDossier PreparationEuropean Procedures ManagementWorksharing and Supergrouping VariationsRegulatory Data Management
Soft Skills
Problem-Solving SkillsClear Communication SkillsTeam-Oriented MindsetSelf-Directed ManagementAnalytical Approach
Tools & Technologies
WordExcelRIMEDMS
Certifications & Qualifications
Master’s Degree in Regulatory Affairs
Industry Keywords
Pharmaceutical VariationsClinical VariationsEuropean Regulatory DevelopmentsCompliance with UPSA PoliciesCross-Functional Collaboration
About the role
Key responsibilities & impact- Provide regulatory expertise to obtain European marketing authorizations.
- Implement the regulatory strategy decisions defined in the Global Regulatory Plan.
- Draft the European Module 1 and coordinate the preparation of complete dossiers with global functions and regional and local regulatory teams.
- Independently manage straightforward European procedures.
- Lead regulatory activities related to worksharing and supergrouping variations.
- Coordinate multiple complex European projects in parallel, covering pharmaceutical and clinical variations.
- Supervise regional and local partners on specific cross-functional activities.
- Manage European regulatory data and documents in UPSA’s internal systems, particularly RIM.
- Monitor European regulatory developments relating to medicinal products.
- Ensure compliance with local regulatory requirements and UPSA policies and procedures.
- Support junior staff, including interns and apprentices.
- Provide backup, as needed, for the Global Regulatory Affairs Core Team Lead on cross-functional R&D projects and lifecycle management topics.
- Develop collaborative relationships with regional stakeholders to ensure alignment and execution of regulatory activities.
Requirements
What you’ll need- Degree in pharmacy or a scientific discipline (chemistry, biology, life sciences, etc.).
- Master’s degree in Regulatory Affairs.
- At least 3 years of experience in a similar Regulatory Affairs role, with proven experience in European procedures.
- Fluency in English and French.
- Proficiency in Word, Excel, RIM, and eDMS (document management/publishing systems).
- Experience with international marketing authorizations would be an advantage.
- Strong business acumen and problem-solving skills.
- Self-directed, with the ability to manage multiple priorities simultaneously.
- Clear and transparent communication skills, with a strong team-oriented mindset.
- Analytical, rigorous, and proactive approach to challenges.
Benefits
Comp & perks- Close-knit and passionate teams.
- Career development opportunities in a fast-growing company.
- A strong social responsibility policy that places employee well-being at the heart of its priorities.
- Do Good, Live Well, Be Well: three commitments that guide the way we work and support every employee.
- Fair treatment and equal opportunities throughout the recruitment process and career development.