Job DescriptionWe are seeking a highly skilled and proactive Global Labeling Specialist to join our Regulatory Affairs team. The ideal candidate will have deep expertise in global labeling processes, regulatory requirements, and cross-functional collaboration to support the development and lifecycle management of product labeling documents.Key ResponsibilitiesDevelop, update, and maintain core labeling documents (CCDS, USPI, SmPC) and manage their global lifecycle and downstream implementation.Lead and optimize global labeling processes, including SOPs, work instructions, training materials, and workshops.Ensure compliance with global regulatory requirements for product labeling.Drive alignment across regulatory, medical, clinical, and other departments to define and execute labeling strategies.Lead Labeling Teams, Review Committees, and Strategy Teams to facilitate decision-making.Proactively identify and resolve regulatory and labeling challenges.Implement labeling changes and ensure compliance throughout downstream processes.Manage multiple labeling projects simultaneously, ensuring timely and quality delivery.Anticipate potential labeling issues and implement effective risk mitigation strategies.Prepare high-quality labeling justifications and responses to health authorities.Translate complex regulatory and scientific data into clear, actionable labeling content.Assess clinical data and safety updates for labeling impact.Utilize labeling tools, tracking systems, and document management platforms effectively.Communicate label update plans to Hub Labeling Managers in a timely and efficient manner.Champion continuous improvement initiatives in collaboration with Labeling Operations Managers and Regulatory Strategists.Required Skills & QualificationsProven experience in regulatory affairs with a focus on labeling.Strong understanding of global regulatory labeling requirements.Excellent written and verbal communication skills.Demonstrated leadership in cross-functional teams and labeling committees.Experience with labeling systems and document management tools.Strong analytical and problem-solving skills.Ability to manage multiple priorities in a fast-paced environment.Preferred QualificationsExperience in pharmaceutical or biotechnology industries.Familiarity with global health authority regulations and submission processes.Top SkillsRegulatory AffairsLabeling Strategy & ComplianceCross-functional Leadership

Pay and Benefits

The pay range for this position is $45.00 - $50.00/hr.

Workplace Type

This is a fully remote position.

À propos d'Actalent:

Actalent est un chef de file mondial des services d’ingénierie et de sciences et des solutions de talents. Nous aidons les entreprises visionnaires à faire progresser leurs initiatives en matière d’ingénierie et de science en leur donnant accès à des experts spécialisés qui favorisent la mise à l’échelle, l’innovation et la mise en marché rapide. Avec un réseau de près de 30 000 consultants et plus de 4 500 clients aux États-Unis, au Canada, en Asie et en Europe, Actalent est au service d’un grand nombre d’entreprises du classement Fortune 500.

Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi.

Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à actalentaccommodation@actalentservices.com pour connaître d’autres options d’accommodement.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.