Senior Regulatory Affairs Associate - Safety Labelling (home or office based)
Parexel · Romania
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Senior Regulatory Affairs Associate to join our dynamic team! This is a client dedicated project, offering flexibility in working location across various European locations, either office or home based.
As the Senior Regulatory Affairs Associate in Safety Labelling, you will plan, coordinate, and deliver global and regional safety labelling activities and regulatory submissions throughout the product lifecycle. You will act as the primary Global Regulatory Affairs contact for assigned safety labelling activities, working closely with client stakeholders, affiliates, and internal cross-functional teams.
Key Responsibilities
- Plan, coordinate, and deliver global and regional safety labelling activities and regulatory submissions throughout the product lifecycle, ensuring timely execution and compliance with applicable regulatory requirements.
- Execute high-quality safety labelling regulatory activities, maintaining compliance with client procedures, regulatory requirements, and internal systems and processes.
- Assess emerging safety information, regulatory commitments, and pharmacovigilance outputs to determine labelling impact, submission requirements, implementation timelines, and associated regulatory risks.
- Author, review, and maintain regulatory documentation, including Module 1 content, and collaborate with subject matter experts and stakeholders to prepare submission-ready dossiers.
- Manage end-to-end safety labelling submissions, including planning, dossier compilation, submission package preparation, RIMS maintenance, health authority query responses, and post-approval implementation activities.
- Serve as the primary Global Regulatory Affairs contact for assigned safety labelling activities, coordinating with client stakeholders, affiliates, and internal cross-functional teams.
- Maintain and oversee global and regional product information, including EU Product Information, ensuring compliance with applicable regulations, QRD requirements, company core labelling documents, and client standards.
- Coordinate and track linguistic review, translation, readability testing, and implementation activities associated with safety labelling updates.
- Support the development, maintenance, and implementation of Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI), and associated local labelling documentation, where applicable.
- Provide regulatory support for safety-related updates arising from Periodic Safety Update Reports (PSURs), signal evaluations, risk management activities, and other pharmacovigilance-driven initiatives.
- Support change control processes related to safety labelling updates and ensure approved changes are implemented within required regulatory timelines.
- Coordinate with publishing, operations, and affiliate teams to support the assembly, validation, submission, and implementation of regulatory dossiers.
- Liaise with health authorities, affiliates, and other stakeholders regarding routine and non-routine safety labelling matters, including responses to regulatory questions and requests for information.
- Monitor and communicate relevant changes to global regulatory requirements, guidance, and labelling standards that may impact product compliance or labelling strategy.
- Develop and maintain submission plans, trackers, metrics, and regulatory records to support inspection readiness, compliance monitoring, and on-time delivery of regulatory commitments.
- Contribute as an active member of cross-functional regulatory and safety governance teams, providing regulatory expertise and support for complex labelling initiatives.
Skills and Experience
- University degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline.
- Working knowledge of global and regional regulatory requirements for medicinal product safety labelling and lifecycle management, including EU labelling requirements.
- Understanding of CCDS, CCSI, and their implementation into product information and artwork.
- Knowledge of safety signal management and the impact of confirmed safety signals on product labelling.
- Understanding of regulatory submission processes, including Module 1 documentation, lifecycle management activities, and health authority interactions.
- Familiarity with Regulatory Information Management Systems (RIMS) and electronic document management systems.
- Strong planning, organizational, and time management skills, with the ability to manage multiple priorities and deadlines.
- Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements and propose practical solutions.
- Excellent communication, stakeholder management, and interpersonal skills, with the ability to collaborate effectively across cross-functional teams.
- Fluent in English, both written and spoken.