Regulatory Affairs Labeling

Join a global clinical research environment dedicated to improving patient outcomes by ensuring accurate, compliant, and up-to-date medicinal product information. In this role, you will oversee regulatory labeling activities throughout the product lifecycle, from initial assessments to post-approval updates. You will evaluate regulatory changes, coordinate product information revisions, and prepare submissions to Health Authorities across multiple regulatory procedures. Working closely with cross-functional teams and client stakeholders, you will help maintain compliance with evolving regulatory requirements. You will also contribute to labeling quality, submission accuracy, and the timely execution of regulatory commitments. This remote opportunity offers exposure to international regulatory processes, specialized systems, and continuous professional development within a collaborative, patient-focused environment.

• Education: Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related discipline, or equivalent professional experience.

• Professional Experience: At least 6 years of experience in regulatory affairs or regulatory labeling, preferably within the pharmaceutical, clinical research, or healthcare industries.

• Regulatory Knowledge: Strong understanding of medicinal product labeling requirements, Health Authority submission processes, and regulatory procedures, including Centralized, Mutual Recognition, Decentralized, and National Procedures.

• Clinical and Scientific Expertise: Ability to assess clinical information and apply relevant knowledge when preparing and updating product information documentation, particularly the CCDS.

• Technical Proficiency: Familiarity with Veeva RIMS and TrackWise for regulatory information management, change control assessment, and post-approval activities.

• Preferred Skills: Experience with the Extended EudraVigilance Product Dictionary (xEVMPD) is an advantage.

• Communication: Fluency in English, with strong written and verbal communication skills for preparing regulatory documentation and coordinating with stakeholders.

• Planning and Organization: Excellent coordination, prioritization, and time-management skills, with the ability to manage multiple submissions and meet deadlines.

• Attention to Detail: A careful, quality-focused approach to regulatory documentation, labeling accuracy, and compliance requirements.

• Collaboration and Adaptability: A proactive, patient-focused mindset and the ability to work effectively with diverse teams and client stakeholders in a fast-paced, regulated environment.