Sponsor Dedicated - Regulatory Labeling Manager

Syneos Health, Inc.; Greater London; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

The Regulatory Labeling Manager for Lifecycle Products at Syneos Health is responsible for development, maintenance, and oversight of labeling content for mature pharmaceutical products. You will author and update labeling documents in response to safety updates and regulatory requirements, coordinating with stakeholders to ensure governance processes are followed.

You will work with internal teams across drug development and commercialization to ensure timely and compliant labeling decisions,

Qualifications

• 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

Responsibilities

• Develop, maintain and oversee labeling content for mature pharmaceutical products.
• Collaborate with internal stakeholders to ensure governance processes are followed.
• Update labeling in response to safety updates and regulatory requirements.

Skills

Labeling negotiations

Safety data interpretation

Structured content tools

eCTD labeling submissions

Biotech Regulatory labeling

Bachelor's degree • Science/Business

Education

Bachelor's degree in Science or Business

Tools

XML-based labeling systems

Structured content authoring tools

Job description

Sponsor Dedicated - Regulatory Labeling Manager

Updated: Today
Location: Remote, LND, United Kingdom
Job ID:25112028-OTHLOC-3526-2DR

Description

Sponsor Dedicated - 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

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.

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 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. The manager collaborates with internal stakeholders to ensure governance processes are followed and labeling decisions are well-documented in accordance with Sponsor's Labeling Procedures.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health ® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.