Regulatory Affairs Specialist

Your Job

As a key member of our team at PharmaLex, you will play a crucial role in the preparation and revision of informative texts for healthcare professionals and patients in the EU and non-EU markets. Your expertise will be essential in developing target product/labelling profiles and ensuring the accuracy and compliance of our labelling documentation.

Your Responsibilities

• Participate in the preparation and revision of informative texts for healthcare professionals and patients in the EU and non-EU markets.
• Develop target product/labelling profiles and ensure the accuracy and compliance of our labelling documentation.
• Manage the creation and maintenance of CCDS/CCSI/RSI, as applicable, in collaboration with relevant departments/expert functions.
• Ensure communication to internal/external stakeholders regarding new and updated CCDSs.
• Evaluate and escalate deviation and compliance issues to the labelling governance bodies as necessary.
• Provide regulatory expertise to regulatory programs and projects, as well as to clients.
• Offer general guidance (consultancy) to PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities.
• Present seminars and lectures on behalf of PharmaLex internally, for customers, and for professional audiences.
• Contribute to the creation, revision, editing, and maintenance of regulatory documentation.
• Engage in professional interaction with clients and Health Authorities.
• Coordinate project teams with internal/external staff and Regulatory Alliance Partners on a worldwide level.
• Participate in strategic regulatory issues, including the definition of suitable methods of resolution.

Your Profile

We are seeking a highly skilled and experienced professional with a strong background in regulatory affairs and labelling activities. Your profile should include:

• Fluent business English or English as your mother tongue, preferably with skills in another EU language.
• A degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in science, engineering, or mathematical domain.
• Professional experience in regulatory affairs with a profound track record in labelling activities for innovator drugs on a global level.
• Experience in handling marketing authorizations and their lifecycle management.
• Sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region.
• Affinity for databases, labelling software tools, and project management software, with the ability to closely monitor and adhere to timelines.
• Excellent communication, teamwork, and problem-solving skills.

We Offer

At PharmaLex, we offer a diverse and challenging job with opportunities for continuous development and growth. Our open and appreciative corporate culture values flexibility, trust, and work-life balance. We provide a range of benefits, including flexible working hours, the possibility to work reduced hours, and the opportunity to work from home. Join our team and take the next step in your career as a Regulatory Affairs Specialist, Global Labelling Manager, or Pharmaceutical Regulatory Expert.