Senior Manager EU Brand Labeling 100%
- Lead the creation and maintenance of regulatory compliant, competitive, and up-to-date EU labeling documents (SmPC, PIL, Labeling) for an assigned portfolio of brand/specialty products
- Provide strategic and operational regulatory labeling guidance
- Ensure compliance with internal labeling policies/processes and assure conformity with EU labeling guidelines/regulations
- Manage the internal labeling review and approval processes
- Lead and/ or contribute to process improvement initiatives
- Organize and lead cross- functional Product Working Groups (PWGs) to reach consensus on EU labelling matters and to prepare high quality EU labeling documents and documents to support labeling changes (e.g. Expert Statements)
- Ensure that key regional/market RA input is sought and incorporated into EU labeling strategy
- Guide and support the local/market RA teams for local labelling-related Health Authority (HA) negotiations to ensure consistency and compliance with the overall EU and global strategy for the brand
- Drive and coordinate responses to Health Authority queries related to related to EU common labeling, and participate in internal audits and Health Authority inspections as required
- Coach and mentor newcomers as well as less experienced EU Brand Labeling Managers
- Deputize for the Head of EU Brand Labeling as required
- Master’s Degree in life science (Pharmaceutical, Regulatory Affairs), preferably with a PhD
- 6-8 years' experience within the Pharma industry
- Minimum of 5 years' experience within Labeling in development projects and/or maintenance products at EU or global level
- Ability to think strategically, assess and evaluate risks and formulate strategies to manage them
- Solid knowledge of EU labeling guidelines and regulations
- Expert proficiency in managing labeling processes and texts at EU or global level
- Excellent written and verbal communication skills
- Keen attention to detail, accurate, process minded and quality driven
- Excellent project management, organizational and strong analytical skills
- Experience in leading cross-functional teams
- Proficiency in English Regulatory Affairs technical language, additional language skills in German and French is an asset
- Working for one of the top 10 global pharmaceutical companies in an international environment
- Innovative position driving the strategy for the development and management of European labeling for an assigned portfolio of brand/specialty products of high priority
- Challenging and responsible position in a motivated team
- Market competitive remuneration package
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Serendi is a recruitment service provider with its headquarters in Switzerland. Our clients are large Swiss or international companies.
We manage the entire recruitment process for our client companies - including sourcing of candidates. Candidates are selected based on how well their experience and qualifications match our clients position requirements.
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