Senior Regulatory Affairs Manager - Global Labeling (m/f/d) 100%
📋 Détails de l'offre
Senior Global Labeling Manager (m/w/d) – Pharmaceutical Regulatory Affairs
Shape the Future of Global Drug Labeling – Your Expertise Matters!
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Duration:
5 months
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Location:
Basel
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Employment Type:
Temporary Assignment
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State:
ASAP
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
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Act as the
primary point of contact
for all labeling-related matters and drive labeling excellence across assigned product portfolios
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Develop, update, and maintain
regulatory-compliant global labeling documents
, including Core Data Sheets (CDS), Basic Patient Leaflets (BPL), and Basic Succinct Statements (BSS)
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Lead
Expert Labeling Task Forces (ELTF)
to establish labeling strategies, facilitate cross-functional alignment, and achieve consensus on labeling content
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Serve as a
core member
of Regulatory Affairs Sub-teams and Safety Management Teams (SMTs) for designated projects and products
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Conduct in-depth research on labeling topics by analyzing international labels, competitor documentation, clinical study data, and regulatory frameworks
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Prepare
high-quality regulatory submissions
supporting CDS modifications and responses to Health Authority inquiries
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Collaborate with Country Organizations to ensure
timely and consistent implementation
of global labeling updates in local product information
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Support Regulatory Affairs activities related to
safety risk communications
and portfolio stewardship initiatives with labeling implications
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Present labeling strategies and updates to relevant boards, forums, and committees (e.g., MSRB, PSB)
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Prepare and review
Periodic Safety Update Report (PSUR)
regulatory input for assigned products
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Review and approve
International Package Leaflets
to ensure regulatory compliance and quality standards
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Provide
mentorship and guidance
to junior team members and new Global Labeling Managers
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Contribute to
continuous improvement initiatives
within global labeling management processes
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Evaluate and provide input on emerging
internal and external regulatory guidelines
affecting labeling practices
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Represent the Global Labeling function during
audits and regulatory inspections
Your Profile
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Academic background:
Bachelor's or Master's degree in life sciences; advanced degree (MD, PhD, PharmD) is highly desirable
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Professional parcours professionnel:
Several years of direct, hands-on Global Labeling experience in the pharmaceutical industry (ideally 4–6+ years) with clear CDS/CCDS ownership (lead author) and labeling change management responsibility
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Fluent in English
as business language; additional language skills are advantageous
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Strong
interpersonal and communication skills
with the ability to influence and negotiate effectively
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Proven ability to
lead cross-functional teams
and manage projects in a matrix organization
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Excellent
organizational awareness
and understanding of business priorities and departmental interdependencies
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Solid knowledge of
medical and scientific terminology
and drug safety information
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Demonstrated
problem-solving capabilities
and strategic thinking skills
What We Offer – Your Benefits with nemensis AG
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nemensis AG
is your specialized personnel partner in the Life Sciences sector, based in Basel
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Comprehensive
consultation and support
throughout the entire application process by our experienced Consultants
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Access to an
extensive client network
and exciting opportunities in Northwestern Switzerland
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Quick and straightforward onboarding
through 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,
E-Mail schreiben
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🏢 À propos de l'entreprise
Entreprise dans le secteur Biotechnologie / Chimie / Pharmaceutique