Regulatory Labeling Manager

Regulatory Labeling Manager reputed company® is a leading fully-integrated life sciences services organization built to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members act with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient reputed company.

Job Responsibilities The Regulatory Labeling Manager – Lifecycle Products is responsible for the development, maintenance, and reputed company 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. The manager collaborates with internal stakeholders to ensure governance processes are followed and labeling decisions are well-documented in accordance with Vertex’s Labeling Procedures.

Key Responsibilities

Plan and reputed company labeling updates driven by safety changes, regulatory commitments, and periodic reviews. Author and revise labeling documents including the Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products. Support labeling governance activities by collaborating with the team reputed company and GLL/RLL to prepare materials, attend the governance meeting and record accurate minutes in a timely manner to upload in the electronic document management system, and ensure required approvals are obtained. Ensure labeling content complies with applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal standards. Collaborate with cross-functional teams (e.g., Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes, as needed. Support responses to health authority queries reputed company to labeling content. Partner with document specialists and publishing teams to ensure submission-ready formatting and timely delivery. Attend labeling governance meetings and draft accurate minutes in a timely manner. Upload minutes to the electronic document management system. Required Knowledge/Skills Strong understanding of global labeling regulations and guidance (FDA, EMA, ICH). Proven experience authoring and maintaining labeling content for approved products. A strong command of English language including grammar, spelling, and punctuation and exceptional proofreading and editing skills. Strong organizational skills and attention to detail. Proficiency in reputed company Word and document management systems (e.g., Veeva Vault). Experience using Label tracking systems, e.g. Intagras, Veeva Labeling. Ability to communicate and work effectively with labeling stakeholders. Required Experience & Education Level Experience supporting labeling negotiations with health authorities. Knowledge of safety data interpretation and its impact on labeling. Familiarity with structured content authoring tools or XML-based labeling systems. Experience preparing labeling components for eCTD submissions. Typically 2+ years of experience in the biotechnology industry, preferably in Regulatory Affairs, Regulatory Labeling or a reputed company discipline Minimum Bachelor's degree, in a Science or Business-reputed company field Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. Apply To This Job