Regulatory Labeling Manager (North America and LATAM Only)
Location: Remote – USA (NY)
Job ID: 25103967
Updated: December 6, 2025
Status: This job posting is no longer active
Position Overview
The Regulatory Labeling Manager is responsible for developing, reviewing, and maintaining compliant labeling and artwork for pharmaceutical products across North America and LATAM regions. This role ensures all product labeling meets FDA, EMA, ICH, and regional regulatory requirements, while supporting cross-functional initiatives related to product launches, lifecycle management, and labeling updates.
This position is open exclusively to candidates based in North America and LATAM. Sponsorship is not available. CVs must be submitted in English.
About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions provider operating across 110 countries with more than 29,000 employees. The organization delivers clinical development, medical affairs, and commercial expertise to help clients accelerate the development and delivery of new therapies.
The company prioritizes employee growth, training, diversity, and a culture where individuals can bring their full selves to work.
Key Responsibilities
Review and approve product labeling artwork, including cartons, inserts, blisters, and labels, ensuring regulatory accuracy and consistency with approved content.
Collaborate with Regulatory Affairs, Packaging, Quality Assurance, and external vendors to drive timely artwork development and updates.
Confirm artwork reflects approved product information such as dosage, administration instructions, warnings, and product identification.
Provide training and oversight to Functional Service Provider (FSP) teams participating in artwork processes.
Ensure compliance with region-specific regulatory standards, including FDA, EMA, ICH, and LATAM health authority guidelines.
Maintain comprehensive documentation of artwork reviews, approvals, and version control, adhering to SOPs and quality standards.
Participate in cross-functional discussions supporting product lifecycle management, labeling updates, and change control processes.
Contribute to labeling and artwork process improvement initiatives to enhance accuracy, efficiency, and compliance.
Required Skills and Competencies
Strong understanding of regulatory labeling regulations (FDA, EMA, ICH).
Exceptional attention to detail with advanced proofreading and quality review capabilities.
Hands-on experience with artwork management platforms such as GLAMS, Esko, or Adobe Illustrator.
Experience with proofreading tools such as TVT and Global Vision.
Ability to work independently while collaborating effectively in a fast-paced global environment.
Strong communication and organizational skills.
Experience Required
Minimum Experience: 4 to 7 years in regulatory labeling, regulatory affairs, pharmaceutical artwork management, or related functions.
Industry Experience: Life sciences, pharmaceuticals, biotechnology, or CRO environments.
Preferred Experience: Lifecycle labeling management, global health authority submissions, artwork version control, and FSP operating models.
Compensation and Benefits
Syneos Health offers competitive compensation based on skills, qualifications, and performance. Benefits may include medical, dental, and vision coverage, company car or car allowance, 401(k) with company match, employee stock purchase program eligibility, performance-based bonuses, and flexible paid leave. Paid sick time availability may vary by location.
Role Summary
The Regulatory Labeling Manager – Lifecycle Products oversees labeling content for mature pharmaceutical products with no ongoing development activities. The position requires authoring and updating labeling documents in line with safety updates, regulatory guidance, and internal review processes. The manager ensures all labeling decisions align with governance procedures and are thoroughly documented.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Netanya | Tel Aviv | Yavne | Kfar Saba | Be'Er Sheva |Remote :
Hungary | McFarland | Faridabad | Thailand | French | Castlebar | Nairobi | Lousiana | Manipal | Green Way | Leinster | Hammond | Remote, USA | Melbourne | Switzerland | Minnesota | Remote | Zaragoza | Belgium | Medan | Blue Bell | Remote - Africa | Riga | Texas | Remote - South America (Latin Americal) | Victoria | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Springville | Tulsa | Lenexa | Bountiful | Bishop | Ireland | Remote - Middle East | Slovakia | Xzagreb |Republic of Colombia :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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