Regulatory Affairs Specialist

Key Responsibilities

• Develop and maintain high-quality labelling and regulatory submissions for pharmaceutical products in EU and non-EU markets.
• Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
• Manage the creation and maintenance of regulatory documents, including CCDS/CCSI/RSI, and ensure timely communication with stakeholders.
• Escalate compliance issues and deviations to labelling governance bodies as necessary.
• Provide regulatory expertise to support the development of pharmaceutical products and ensure regulatory affairs, development consulting, and scientific affairs programs are delivered to high standards.
• Plan and expedite approval projects using software tools, databases, and document management systems.
• Offer regulatory guidance to PharmaLex staff and customers on regulatory submissions and labelling activities.
• Present seminars and lectures on regulatory topics to internal and external audiences.

Requirements

• Fluent business English or English as a native language, with proficiency in another EU language.
• Relevant degree in pharmacy, medicine, or life sciences, or a bachelor's degree in science, engineering, or mathematics.
• Proven experience in regulatory affairs, with a strong 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, labeling software tools, and project management software, with the ability to closely monitor and adhere to timelines.
• Strong communication, teamwork, and problem-solving skills.

Benefits

• Diverse and challenging job opportunities.
• Open and appreciative corporate culture.
• Flexible working hours based on trust.
• Possibility to work reduced number of hours.
• Possibility to work from home.
• Continuous development opportunities through knowledge and experience as well as training.