Regulatory Labeling Manager

Regulatory Labeling Manager

Syneos 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.

Our Clinical Solutions team members act with a drug development mindset, 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 achieve 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 Syneos Health
• 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 all want to work for and our customers want to work with. Why? Because we know that when 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 progress. 

Job Responsibilities

The Regulatory Labeling Manager – 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. 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 lead 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 lead 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 related 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 Microsoft 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 related discipline 
• Minimum Bachelor's degree, in a Science or Business-related field

Get to know Syneos Health

Over 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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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 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

Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.