Senior Global Labeling Manager – Pharma, Regulatory Affairs vacancy for our Basel based client in the Pharma sector.

Your tasks:

• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes.
• Fulfill labeling responsibilities to achieve business objectives for assigned products and brands.
• Timely management of core labeling documents for the assigned products and brands. Ensure labeling strategy is presented to relevant boards.
• Collaborate with ELTF to minimize NPI deviations (escalating as appropriate) and document rationale for deviations appropriately.
• Serve as the labeling lead for all labeling related topics.
• Maintain regulatory compliant, competitive and up to date global labeling documents.
• Organise and lead the ELTF to discuss labeling strategy and reach consensus.
• Research and understand the labeling topic including reviewing labels across different markets.
• Interact with COs to ensure timely implementation of global labeling changes.

Your experience/knowledge:

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.
• Special expertise and seniority in the listed activities.
• Extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience (5 + years) in related areas of the pharmaceutical industry or Health Authorities.
• Contribute to/lead presentations on labeling related topics for the assigned products at relevant board/forum/committee (e.g., MSRB, PSB).
• Prepare and/or review PSUR RA input for assigned products.
• Review and release International Package Leaflets for assigned products.
• Mentor newcomers and less experienced GLMs.
• Contribute to global labeling management and continuous improvement initiatives.
• Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
• Represent GL during audits and inspections.
• Language skills: English – fluent

Your soft skills:

• trong interpersonal, project management, communication, negotiation and problem solving skills.
• Ability to lead cross-functional teams in a matrix environment
• Organizational awareness (interrelationship of departments, business priorities)
• Sound understanding of medical and scientific terminologies
• Good understanding of drug safety information

Location: Basel, Switzerland
Work setting: Hybrid
Sector: Pharma
Start: ASAP
Duration: 10+ months
Workload: 100%
Ref.Nr.: BH 23475

Take the next step and send us your resume along with a daytime phone number where we can reach you.

Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens, and current work-permit holders for Switzerland.

We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.

As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.