Regulatory Labeling Manager (NA and LATAM Only)

Syneos Health • USA-MA-Remote, MA

8d

About The Position

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.

Requirements

• 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.

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.

Benefits

• company car or car allowance
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• flexible paid time off (PTO) and sick time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed