Regulatory Affairs Global Labeling Product Leader

Job title:

Regulatory Affairs Global Labeling Product Leader

Company:

Randstad

Job description

we are looking for a Senior Manager, Global Labelling to be responsible for the labelling strategy for pharmaceutical products in international markets. The role requires close collaboration with global and regional teams and subject matter experts to ensure documentation is in line with regulatory requirements and business strategy.the incumbent will manage the processes for developing, approving and updating labelling documents, coordinate the Labeling Working Group and Labeling Committee teams and liaise with regulatory authorities.Regulatory Affairs Global Labeling Product Leader Nr ref.: 546/1/2025/PR/259469/jobs.pl Warszawa (mazowieckie)What we offer

• the opportunity to work in a global environment and contribute to projects of international importance.
• professional development in regulatory affairs and labelling strategy.
• flexible working hours and some remote working opportunities.
• work with international teams and have access to the latest trends in pharmaceutical regulation.

Your tasks

• development and maintenance of labelling documents (Global Core Label, USPI, EU PI and others).
• managing the labelling strategy in line with the global regulatory strategy.
• work closely with subject matter experts (SMEs), Global Regulatory Affairs and Global Labeling Office teams.
• leading the Labeling Working Group and Labeling Committee to agree product label content.
• ensure compliance of documentation with regulatory requirements and consistency between documents.
• monitoring regulatory developments in international markets and their impact on product labelling.
• liaise with external partners on product labelling where required.
• supporting audit and quality control activities for label documentation.
• implement continuous process improvement initiatives related to global labelling.

What we expect

• university degree in Life Sciences, Pharmacy or related field (MS, PhD, MD or PharmD preferred).
• minimum 6 years’ experience in regulatory affairs, including pharmaceutical labelling.
• knowledge of international labelling regulations.
• experience of working in a global environment and working with teams in different time zones.
• ability to write and edit labelling documents in accordance with regulatory requirements.
• very good knowledge of English (written and spoken).
• strong communication, negotiation and organisational skills.
• knowledge of documentation management tools (e.g. Microsoft Word, Document Management Systems).

Employment agency entry number 47this job offer is intended for people over 18 years of age

Expected salary

Location

Warszawa, mazowieckie

Job date

Sat, 01 Feb 2025 23:44:45 GMT

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