Hobson Prior are looking for a Regulatory Labelling Consultant to join a top Biotechnology organisation who specialise within Rare Diseases. This position will be home-based with the occasional travel to Marburg.

Job Responsibilities:

• Accountable for the implementation of new and updated Company Core Data Sheets of the company's products in the regional/local labeling of the assigned Region within the set timeframe.
• Track region/country specific deviations from the CCDS and brings these deviations to the attention of the CCDS owner for decision making.
• Interaction with relevant stakeholders like the CCDS owners, the points of contacts in the Region boundaries, and local commercial organizations, as applicable.
• Ensure compliance with the regional/country specific regulatory requirements and procedures governing leaflets and labeling (i.e. General regulations, readability guideline, health authority templates, etc.).
• Ensure compliance of region/country specific labeling texts with the CCDS.
• Ensure that printed packaging materials are updated subsequent to labeling changes.
• Arrange translations of product labeling texts as required and in collaboration with local offices/third parties.
• Plan and manage readability user tests, as needed (EU specific)
• Maintain labeling databases and systems (PAS, GRDC), as needed.
• Contribute to an efficient and compliant end-to-end global labeling process.
• Participate in projects to implement and improve labeling processes and systems.

Key Skills:

• Excellent oral, written and interpersonal communication skills in English.
• Planning, organizing and time management skills.
• Attention to detail.
• Ability to work well under pressure.

Requirements:

• University degree or equivalent in a scientific discipline.
• Experience in a Global Regulatory Affairs function with knowledge of regulatory product labeling and related processes.
• Competence in documentation practices.
• Understanding of GMP compliance, quality control procedures and documentation practices.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.