Senior Regulatory Affairs Associate – Safety Labelling

This is a fully remote position, open to applicants in Romania, +4 more countries.

📋 Description

• Strategize, coordinate, and execute global and regional safety labelling initiatives and regulatory submissions throughout the entire product lifecycle.

• Implement safety labelling regulatory tasks while ensuring adherence to client procedures, regulatory mandates, and internal systems and processes.

• Evaluate new safety information, regulatory obligations, and pharmacovigilance results to assess the impact on labelling, submission necessities, implementation timelines, and regulatory risks.

• Draft, review, and manage regulatory documentation, including Module 1 content, while preparing submission-ready dossiers in collaboration with subject matter experts and stakeholders.

• Oversee comprehensive safety labelling submissions, which involve planning, dossier compilation, submission package preparation, RIMS upkeep, health authority query responses, and post-approval implementation.

• Act as the main Global Regulatory Affairs liaison for designated safety labelling initiatives.

• Maintain and supervise global and regional product information, including EU Product Information.

• Facilitate linguistic reviews, translation, readability testing, and implementation tasks for updates to safety labelling.

• Assist in the development, maintenance, and implementation of CCDS, CCSI, and related local labelling documentation.

• Provide regulatory assistance for safety-related updates stemming from PSURs, signal evaluations, risk management activities, and other pharmacovigilance efforts.

• Support change control processes and ensure that authorized modifications are executed within the necessary regulatory timelines.

• Collaborate with publishing, operations, and affiliate teams on the assembly, validation, submission, and implementation of regulatory dossiers.

• Communicate with health authorities, affiliates, and stakeholders regarding safety labelling issues and regulatory inquiries.

• Observe and relay updates on global regulatory requirements, guidelines, and labelling standards.

• Create and maintain submission plans, trackers, metrics, and regulatory records to ensure inspection readiness and compliance monitoring.

• Participate in cross-functional regulatory and safety governance teams.

⛳️ Requirements

• A university degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific field.

• Practical knowledge of global and regional regulatory standards for medicinal product safety labelling and lifecycle management, including EU labelling requirements.

• Comprehension of CCDS, CCSI, and their integration into product information and packaging.

• Awareness of safety signal management and the implications of confirmed safety signals on product labelling.

• Understanding of regulatory submission processes, including Module 1 documentation, lifecycle management activities, and interactions with health authorities.

• Familiarity with Regulatory Information Management Systems (RIMS) and electronic document management systems.

• Strong planning, organizational, and time management abilities, capable of handling multiple priorities and deadlines.

• Solid analytical and problem-solving skills, with the capacity to interpret regulatory requirements and suggest practical solutions.

• Excellent communication, stakeholder management, and interpersonal skills, with the ability to work effectively across cross-functional teams.

• Proficient in English, both written and spoken.

🏝️ Benefits

• Flexibility in work location across various European sites.

• Options for home-based or office-based work.