Senior Regulatory Affairs Manager - Global Labeling (m/f/d) 100%
Description du poste
Senior Global Labeling Manager (m/w/d) – Pharmaceutical Regulatory Affairs
- Shape the Future of Global Drug Labeling – Your Expertise Matters!Duration:01. 2026Location:Basel
- Employment Type:Temporary Assignment
- Hourly Rate:CHF 54. 00/h to CHF 73. 00/h
- About Our Client
- For our client, a renowned pharmaceutical enterprise in the Basel region, we are seeking an experienced Senior Global Labeling Manager (m/w/d). This innovative organization operates at the forefront of drug development and regulatory excellence, committed to delivering transformative therapies to patients across international markets. With a strong focus on scientific advancement and regulatory compliance, the company plays a leading role in shaping global healthcare standards. Your Responsibilities
- Act as theprimary point of
CONTACT
for all labeling-related matters and drive labeling excellence across assigned product portfolios
- Develop, update, and maintainregulatory-compliant global labeling documents, including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS) Lead
- Expert Labeling
TASKS
Forces (ELTF)to establish labeling strategies, facilitate cross-functional alignment, and achieve consensus on labeling content
- Serve as acore memberof Regulatory Affairs Sub-teams and Safety Management Teams (SMTs) for designated projects and products
- Conduct in-depth research on labeling topics by analyzing international labels, competitor documentation, clinical study data, and regulatory frameworks
- Preparehigh-quality regulatory sub
MISSIONS
supporting CDS modifications and responses to Health Authority inquiries
- Collaborate with Country Organizations to ensuretimely and consistent implementationof global labeling updates in local product information
- Support Regulatory Affairs activities related tosafety risk communicationsand portfolio stewardship initiatives with labeling implications
- Present labeling strategies and updates to relevant boards, forums, and committees (e. , MSRB, PSB) Prepare and review
- Periodic Safety Update Report (PSUR)regulatory input for assigned products
- Review and approve
- International Package Leafletsto ensure regulatory compliance and quality standards
- Providementorship and guidanceto junior team members and new Global Labeling Managers
- Contribute tocontinuous improvement initiativeswithin global labeling management processes
- Evaluate and provide input on emerginginternal and external regulatory guidelinesaffecting labeling practices
- Represent the Global Labeling function duringaudits and regulatory inspections
YOUR PROFILE
Academic background:Bachelor's or Master's degree in life sciences; advanced degree (MD, PhD, PharmD) is highly desirable
- Professional experience:Minimum4-6 years of specialized experiencein global pharmaceutical labeling, or5+ yearsin related pharmaceutical industry roles or Health Authority positions
- Fluent in Englishas business language; additional language skills are advantageous
- Stronginterpersonal and communication skillswith the ability to influence and negotiate effectively
- Proven ability tolead cross-functional teamsand manage projects in a matrix organization
- Excellentorganizational awarenessand understanding of business priorities and departmental interdependencies
- Solid knowledge ofmedical and scientific terminologyand drug safety information
- Demonstratedproblem-solving capabilitiesand strategic thinking skills
- What
WE OFFER
– Your Benefits with nemensis AGnemensis AGis your specialized personnel partner in the Life Sciences sector, based in Basel
- Comprehensiveconsultation and supportthroughout the entire
APPLICATION
process by our experienced Consultants
- Access to anextensive client networkand exciting opportunities in Northwestern Switzerland
- Quick and straightforward onboardingthrough individual guidance and personalized support during the recruitment process
- Ready for Your Next Career Move?At nemensis AG, we've already connected thousands of professionals with their dream jobs, giving them the opportunity to develop further or re-enter the job market. What can we do for you and your career today?Get in touch with us!?Phill Rogers, Consultant,Phillip. Rogers@nemensis. com
- You're looking for a change of perspective, but this isn't the right position for you? Then register with us – we'll
CONTACT
you for an initial meeting to understand your wishes and needs and align ourselves accordingly.
🎯 Maximisez vos chances de décrocher cet emploi !
Un CV professionnel augmente vos chances de 87% d'obtenir un entretien. Nos experts de CVSuisse.com créent des CV qui se démarquent et convainquent les recruteurs.
Commander mon CV professionnel