[Hiring] Regulatory Affairs Labeling @Parexel

Role Description

We are seeking a Regulatory Labeling Specialist to join our team in a remote capacity. As a Regulatory Labeling Specialist, you will ensure that medicinal product information remains accurate, compliant, and current throughout its lifecycle. Accurate labeling helps patients and healthcare professionals get the information they need about medicines. This position plays a key role in regulatory impact assessment, product information management, Health Authority submissions, and post-approval compliance. You will collaborate with cross-functional teams and client stakeholders, follow industry-standard processes, and contribute to regulatory and labeling operations from planning through post-approval activities.

Responsibilities include:

• Assessing the regulatory impact of change controls.
• Managing product information and labeling updates.
• Preparing Health Authority submissions.
• Driving post-approval activities in Veeva RIMS.

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory impact assessment, product information management, and Health Authority submissions.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field, or equivalent professional experience.
• 6+ years of experience in regulatory affairs or regulatory labeling.
• Knowledge of regulatory requirements and Health Authority submission processes for medicinal product labeling.
• Clinical expertise to support product information and CCDS updates.
• Knowledge of Veeva RIMS.
• Fluent in English.
• Strong communication, organization, and planning skills.

Requirements

• Strong coordination skills and the ability to work effectively with team members and client stakeholders.
• Strong planning skills, including planning variation submissions so they are completed on time and to the required quality to meet KPIs.
• Clear communication skills and a collaborative, team-oriented approach.
• Experience working in clinical research, healthcare, or a regulated environment.
• A patient-focused mindset and strong attention to detail.
• Comfort working with Veeva RIMS and TrackWise.

Preferred Qualifications

• Experience with xEVMPD.

Benefits

• Flexibility in work arrangements.
• Opportunities for growth and continuous learning.
• A collaborative team environment where contributions shape the future of clinical research.