THE POSITION

As a (Senior) Global Labeling Lead, your responsibilities will include the development and maintenance of Labeling documents throughout a product’s lifecycle. This spans from the Target Label created very early during clinical development, to the later Company Core Data Sheet for medicinal products, and the Company Core Instructions for Use for medical devices. You will serve as a key member of the Regulatory Excellence Team in GRA, and you will lead the interdisciplinary Labeling Team of an asset.
As a labeling expert, you will be a crucial global contact, guiding various functions, including our affiliates, on global labeling language, strategies and regulations.
If you are passionate about making a difference in the pharmaceutical industry, with expertise in regulatory affairs and labeling, we would like to hear from you. Join us and contribute to our mission of bringing innovative health solutions to patients around the world.

REQUIREMENTS

• Master’s degree in life sciences, with a preference for candidates with a PhD or MD; other additional qualifications, such as Specialized Pharmacist or Master of Drug Regulatory Affairs, are highly welcomed
• In-depth knowledge in pharmacology and/or medicine, preferably with a focus on drug development
• Several years professional experience in Regulatory Affairs or other relevant discipline, e.g., Pharmacovigilance paired with know-how in Labeling and in labeling strategy and development
• Ability to translate scientific content into labeling language
• Experience in international and cross-functional processes, project management and optimization as well as mentoring people
• Excellent oral and written communication, presentation, and negotiation skills in English

ADDITIONAL REQUIREMENTS FOR THE SENIOR GLOBAL LABELING LEAD:

• Substantial professional experience in Regulatory Affairs or other relevant disciplines, such as Pharmacovigilance or Medicine
• Extensive experience in Labeling, with profound knowledge in labeling strategy and development
• Strong ability to lead and influence across international, cross-functional projects

TASKS & RESPONSIBILITIES

• As (Senior) Global Labeling Lead, you will be responsible for our developmental and marketed products/projects. Your role will be pivotal in driving the delivery of robust labeling strategies to feed into the set-up of pivotal trials, and in providing labeling language and guidance for timely regulatory submissions, in line with our global regulatory plans.
• You will be tasked with creating the first labeling statements & strategies during clinical development based on our asset vision as well as the development and maintenance of the Company Core Data Sheet (CCDS) for our medicinal products/ the Company Core Instructions for Use (CC IFU) for our medical devices once the non-clinical and clinical data are emerging. In addition, you will defend labeling strategies and related updates in front of the senior executive committee for labeling.
• Leading the interdisciplinary Labeling Team of an asset will be one of your key responsibilities. You will drive and guide product labeling related discussions throughout the product life cycle and drug development.
• We will rely on you to develop and maintain the EU Product Information (EU PI; Annex I-III) for submission in the EU of our centrally approved products and/or products registered via MRP/DCP procedure.
• You will also take the lead in preparing and reviewing responses to Health Authority or Device Registration Body requests relevant to labeling during first registrations and beyond.
• With your expertise in the regulatory landscape, we expect you to proactively and constantly assess and optimize our Global Labeling specific processes. Your role will ensure compliance with labeling relevant legal and regulatory requirements, and you will lead strategic labeling initiatives.
• As a mentor and contact person, you will provide guidance and support to other Global Labeling colleagues.

ADDITIONAL TASKS FOR THE SENIOR GLOBAL LABELING LEAD:

• As a Senior Global Labeling Lead, you will take charge of strategic projects/products that have a broader scope or higher level of complexity, for example requiring in-depth knowledge of a therapeutic area, and/or managing several indications for one product.
• You will also be responsible for translating strategic direction into relevant projects and deputize for the Head of Global Labeling Content Team I or Team II.