Regulatory Labeling Manager (North America & LATAM Only) – Remote
Updated: December 6, 2025
Location: USA–OR–Remote
Job ID: 25103967
Company: Syneos Health
About the Role
Syneos Health is seeking a qualified Regulatory Labeling Manager to support global artwork review, lifecycle labeling management, and compliance processes for mature pharmaceutical products. This remote role is open exclusively to candidates based in North America and LATAM and requires strong regulatory expertise, exceptional quality control skills, and hands-on experience with artwork and labeling systems.
You will collaborate cross-functionally with Regulatory Affairs, Packaging, Quality Assurance, and global labeling teams to develop accurate labeling content, maintain regulatory compliance, and support continuous improvement of labeling processes.
Key Responsibilities
Review and approve labeling artwork including cartons, blisters, inserts, and package labels for accuracy, compliance, and alignment with approved product information.
Ensure artwork reflects updated prescribing information, including dosage, administration instructions, safety warnings, and identification details.
Collaborate with key stakeholders such as Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors for timely artwork development.
Lead and train additional Functional Service Provider (FSP) resources involved in artwork and labeling activities.
Ensure compliance with regulatory requirements across regions including FDA, EMA, ICH, and other global authorities.
Maintain accurate documentation, version control, and audit-ready records in accordance with internal SOPs.
Participate in cross-functional meetings related to product launches, labeling changes, and change control initiatives.
Support labeling process improvements, system enhancements, and workflow optimization.
Required Knowledge and Skills
Strong understanding of regulatory labeling standards and guidelines (FDA, EMA, ICH).
Excellent proofreading ability with strong attention to detail.
Hands-on experience with artwork management systems (GLAMS, Adobe Illustrator, Esko).
Familiarity with proofreading tools (TVT, Global Vision).
Ability to work effectively both independently and within cross-functional teams.
Strong organizational, communication, and documentation skills.
Experience Required
Minimum 5–7 years of experience in regulatory labeling, regulatory affairs, artwork management, or lifecycle labeling functions within the pharmaceutical or biotechnology industry.
Proven experience supporting labeling for commercial or mature products.
Experience working with cross-functional teams and global regulatory requirements.
Prior experience coordinating labeling updates, content reviews, or artwork submissions preferred.
Compensation and Benefits
Syneos Health provides a comprehensive compensation and benefits program, which may include:
Medical, Dental, and Vision coverage
Company-matched 401(k)
Eligibility for Employee Stock Purchase Plan
Performance-based bonus opportunities
Company car or car allowance (where applicable)
Flexible paid time off and sick leave
Additional region-specific benefits based on work location
Salary is determined based on experience, skills, qualifications, and role-related competencies.
About Syneos Health
Syneos Health is a global leader in integrated biopharmaceutical solutions, operating in more than 110 countries with a team of over 29,000 professionals. The organization has contributed to:
94 percent of all Novel FDA-Approved Drugs
95 percent of EMA-Authorized Products
More than 200 studies across 73,000 sites and 675,000+ trial participants
Syneos Health fosters a culture focused on professional growth, scientific excellence, and global collaboration.
Role Summary
The Regulatory Labeling Manager – Lifecycle Products oversees the development, maintenance, and governance of labeling content for mature pharmaceutical products. This includes authoring updates driven by safety requirements, regulatory changes, and internal assessments. The role requires ensuring that labeling decisions comply with established governance processes and organizational labeling procedures.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
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 :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | St. Helena | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |New York :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Tallinn |Hà Nội :
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Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
Bishop | Melbourne | Switzerland | Nairobi | Slovakia | Lenexa | Xzagreb | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Green Way | Remote, USA | Texas | Ireland | Springville | Hammond | Remote - South America (Latin Americal) | Zaragoza | Minnesota | Remote | Medan | French | Tulsa | Hungary | Faridabad | Remote - Middle East | Victoria | Lousiana | Thailand | Remote - Africa | Manipal | Castlebar | Riga | Leinster | Belgium | Bountiful | McFarland |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
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