Regulatory Affairs Manager (Labelling)

Regulatory Affairs Manager with experience in labelling (home based)

We are recruiting for a Regulatory Affairs Manager with experience within labelling and people management to join our global regulatory affairs department. This will be home based position in Poland (preferred locations: Gdańsk, Poznań, Wrocław, Kraków).

OVERVIEW:

The Regulatory Affairs Manager has overall accountability for creation and update of Company Core Data Sheet (CCDS) including Core Safety Information (CSI). Acts as project lead to the labeling team located abroad throughout the entire process, from the decision to update a CCDS/CSI through notification to stakeholders in order to ensure that these documents are of high quality and are delivered in a timely manner according to SOPs and external regulatory requirements.

Key responsibilities:

•            Serves primary point of contact for Labeling Teams and will provide direction to Labeling Specialists so that strategy for labeling content can be prepared and managed appropriately.

•            Prioritize Labeling Team activities and set clear targets using project management tools.

•            Follow up with Labeling Team members to secure their contributions so that internal and external deadlines are met.

•            Identify and assist teams to overcome barriers in achieving quality and compliance.

•            Organize and lead cross functional labeling discussions to reach consensus on global labelling matters and prepare supporting documents for CCDS changes.

•            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 global labeling during audits and inspections.

Requirements:

•            Master degree in life sciences.

•            At least 5 years relevant experience gained in an international pharmaceutical company.

•            Extensive knowledge and experience with pharmaceutical medicinal product information and labelling.

•            People management experience.

•            Expertise in managing regulatory projects.

•            Expert in planning and delivering work on time keeping quality parameter in mind.

•            Ability to establish and maintain effective working relationships with coworkers and managers.

•            Excellent verbal and written communication skills in English.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.