Talent.com
Regulatory Labeling Manager (NA and LATAM Only)
Regulatory Labeling Manager (NA and LATAM Only)Syneos Health/ inVentiv Health Commercial LLC • Omaha, NE, United States
Regulatory Labeling Manager (NA and LATAM Only)

Regulatory Labeling Manager (NA and LATAM Only)

Syneos Health / inVentiv Health Commercial LLC • Omaha, NE, United States
2 days ago
Job type
  • Full-time
Job description

Regulatory Labeling Manager (NA and LATAM Only)

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.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

  • Open to hiring in North America and LATAM only with no sponsorship needs.
  • Please submit CVs in English
  • Key Responsibilities

  • Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content.
  • Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development.
  • Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification.
  • Training and oversight of additional FSP resources for artwork management
  • Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities.
  • Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs.
  • Participate in cross-functional meetings to support product launches, labeling updates, and change control processes.
  • Support continuous improvement initiatives related to artwork review processes and labeling systems.
  • Required Knowledge / Skills

  • Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH).
  • Detail-oriented with excellent proofreading and quality control skills.
  • Familiarity with artwork management systems (e.g., GLAMS, Adobe Illustrator, Esko).
  • Familiarity with proofreading tools (e.g., TVT, Global Vision).
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Strong communication and organizational skills.
  • At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

    Salary Range :

    The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

    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.

    Create a job alert for this search

    Manager Labeling • Omaha, NE, United States

    Related jobs
    Travel Cath Lab Tech - $2,840 per week in North Platte, NE

    Travel Cath Lab Tech - $2,840 per week in North Platte, NE

    AlliedTravelCareers • Bellevue, Nebraska, US
    Full-time
    AlliedTravelCareers is working with FlexCare to find a qualified Cath Lab Tech in North Platte, Nebraska, 69101!.FlexCare is a nationwide leader in the staffing of travel nurses and clinicians.With...Show more
    Last updated: 30+ days ago • Promoted
    Travel Sterile Processing Tech - $1,300 per week in Scottsbluff, NE

    Travel Sterile Processing Tech - $1,300 per week in Scottsbluff, NE

    AlliedTravelCareers • Bellevue, Nebraska, US
    Full-time +1
    AlliedTravelCareers is working with Lancesoft Inc.Sterile Processing Tech in Scottsbluff, Nebraska, 69361!.Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization.We have bee...Show more
    Last updated: 30+ days ago • Promoted
    Manager, Premium Tax

    Manager, Premium Tax

    Argonaut Management Services, Inc • Omaha, NE, United States
    Full-time
    Argo Group International Holdings, Inc.American National, US based specialty P&C companies, (together known as BP&C, Inc. Brookfield Wealth Solutions, Ltd.BWS"), a New York and Toronto-listed public...Show more
    Last updated: 11 hours ago • Promoted • New!
    Senior Manager, Regulatory Affairs (Biosimilars)

    Senior Manager, Regulatory Affairs (Biosimilars)

    Fresenius Kabi USA, LLC • Omaha, NE, United States
    Full-time
    The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find...Show more
    Last updated: 17 days ago • Promoted
    Travel Nurse - RN - LD - Labor and Delivery

    Travel Nurse - RN - LD - Labor and Delivery

    Medical Solutions • Blair, NE, US
    Full-time
    Medical Solutions is seeking an experienced Labor and Delivery Registered Nurse for an exciting Travel Nursing job in Blair, NE. Shift : 3x12 hr days Start Date : ASAP Duration : 13 weeks.A facility in...Show more
    Last updated: 3 days ago • Promoted
    Manager, RFP Writing

    Manager, RFP Writing

    Medica • Omaha, NE, United States
    Full-time
    Medica is a nonprofit health plan with more than a million members that serves communities in Minnesota, Nebraska, Wisconsin, Missouri, and beyond. We deliver personalized health care experiences an...Show more
    Last updated: 30+ days ago • Promoted
    Specialist, Academic Development

    Specialist, Academic Development

    Relativity • Omaha, NE, United States
    Full-time
    The Specialist, Academic Development focuses on researching, approaching, and signing law schools to Relativity's Academic program. This role requires ingenuity and grit to build relationships with ...Show more
    Last updated: 8 days ago • Promoted
    Travel LPN / LVN

    Travel LPN / LVN

    Nationwide Therapy Group • Missouri Valley, IA, US
    Full-time
    Nationwide Therapy Group is seeking a LPN / LVN for a travel job in Missouri Valley, Iowa.Job Description & Requirements. Nationwide Therapy Group Job ID #34917147.Pay package is based on 8 hour...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Labor & Delivery - $2,250 per week in Blair, NE

    Travel Nurse RN - Labor & Delivery - $2,250 per week in Blair, NE

    TravelNurseSource • Blair, NE, US
    Full-time
    TravelNurseSource is working with Medical Solutions to find a qualified Labor / Delivery RN in Blair, Nebraska, 68008!.A facility in Blair, NE is seeking its next amazing RN (Registered Nurse) to wor...Show more
    Last updated: 2 days ago • Promoted
    Remote AI Content Reviewer

    Remote AI Content Reviewer

    Outlier • Bellevue, NE, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 2 days ago • Promoted
    Travel LPN / LVN - Long Term Care (LTC) Long Term Care

    Travel LPN / LVN - Long Term Care (LTC) Long Term Care

    Assured Nursing • Missouri Valley, IA, US
    Full-time
    Assured Nursing is seeking a LPN / LVN Long Term Care (LTC) Long Term Care for a travel job in Missouri Valley, Iowa.Job Description & Requirements. Assured Nursing Job ID #35061644.Pay package ...Show more
    Last updated: 30+ days ago • Promoted
    Remote Bilingual Spanish Legal Expert - AI Trainer ($40-$90 per hour)

    Remote Bilingual Spanish Legal Expert - AI Trainer ($40-$90 per hour)

    Mercor • Bellevue, Nebraska, US
    Remote
    Full-time
    Mercor is seeking • •native Spanish speakers • • who are also • •legal professionals • • based in • •Latin America or Spain • •. This role combines your • •legal expertise • • across a wide variety of different...Show more
    Last updated: 9 hours ago • Promoted • New!
    Account Manager Urology / Oncology - (Remote In Territory)

    Account Manager Urology / Oncology - (Remote In Territory)

    Tolmar • Omaha, NE, United States
    Remote
    Full-time
    Candidates Must Reside in the Omaha, NE Area •.Under limited supervision, the AMR-UO is responsible for achieving sales objectives in assigned territory through the development, maintenance, and enh...Show more
    Last updated: 30+ days ago • Promoted
    Sr Director Rebate Invoice and Audit - Synergie Medication Collective

    Sr Director Rebate Invoice and Audit - Synergie Medication Collective

    Blue Cross Blue Shield Association • Omaha, NE, United States
    Full-time
    The hiring range for this role is : .This is the lowest to highest salary we.A candidate's position within the.Note : No amount of pay is considered to be wages or compensation until such amount is ea...Show more
    Last updated: 15 days ago • Promoted
    Remote Biology Labeling Expert – US - AI Trainer ($50-$60 per hour)

    Remote Biology Labeling Expert – US - AI Trainer ($50-$60 per hour)

    Mercor • Bellevue, Nebraska, US
    Remote
    Part-time
    Mercor is seeking • •PhD holders, doctoral candidates, and outstanding Master’s graduates • • in • •biology and related disciplines • • to join a • •high-impact AI research initiative • • in partnership wit...Show more
    Last updated: 9 hours ago • Promoted • New!
    Travel Cath Lab Tech - $2,957 per week in Omaha, NE

    Travel Cath Lab Tech - $2,957 per week in Omaha, NE

    AlliedTravelNetwork • Bellevue, Nebraska, US
    Full-time
    AlliedTravelNetwork is working with Medical Solutions to find a qualified Cath Lab Tech in Omaha, Nebraska, 68122!.A facility in Omaha, NE is seeking its next amazing Cath Lab Technologist.Read on ...Show more
    Last updated: 20 days ago • Promoted
    AI Trainer -Remote Editorial Specialist

    AI Trainer -Remote Editorial Specialist

    Outlier • Bellevue, NE, United States
    Remote
    Full-time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show more
    Last updated: 2 days ago • Promoted
    Clinical Laboratories Business Development Manager - Mountain Region

    Clinical Laboratories Business Development Manager - Mountain Region

    QuidelOrtho • Omaha, NE, United States
    Full-time
    QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecula...Show more
    Last updated: 30+ days ago • Promoted