Description Sponsor Dedicated - Regulatory Labeling ManagerSyneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Why Syneos Health• We are passionate about developing our people, through career development and progression; technical and therapeutic area training; peer recognition and total rewards program.• We are committed to building an inclusive culture - where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. Job ResponsibilitiesThe Regulatory Labelling Manager for Lifecycle Products is responsible for the development, maintenance, and oversight of labelling content for mature pharmaceutical products (product that have no additional development activities ongoing). This role involves authoring and updating labelling documents in response to safety updates, regulatory requirements, and internal assessments. Knowledge of safety data interpretation and its impact on labelling.• Familiarity with structured content authoring tools or XML-based labelling systems.• Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labelling or a related discipline• Minimum Bachelor's degree, in a Science or Business-related fieldGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.Further, nothing contained herein should be construed to create an employment contract. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.Summary The Regulatory Labeling Manager for Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products (product that have no additional development activities ongoing). This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements, and internal assessments.
Regulatory Manager in London employer: Syneos Health
At Syneos Health, we pride ourselves on being an exceptional employer that prioritises the growth and development of our employees. With a strong commitment to career progression, comprehensive training, and a supportive work culture, we foster an inclusive environment where diverse perspectives are valued. Our remote monitoring role offers the unique advantage of flexibility while contributing to meaningful clinical research that impacts lives across the UK.
