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Senior Regulatory Affairs Consultant - Labeling (European Expertise)

Senior Regulatory Affairs Consultant - Labeling (European Expertise)

Massachusetts StaffingBoston, MA, US
4 days ago
Job type
  • Full-time
Job description

Senior / Consultant, Regulatory Labeling

Incredible, high-impact role with a Global Biopharma sponsor! Are you ready to turn your labeling expertise into strategic impact? We're seeking a sharp, detail-driven Senior / Consultant to join a dedicated partnership with a leading global biopharmaceutical company. In this high-visibility role, you'll be more than a consultantyou'll be a trusted collaborator whose insights help shape regulatory strategy and ensure patients worldwide receive safe, effective therapies with clarity and confidence.

In this role, you'll be the go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs, Technical Operations, Safety, and Commercial. You'll help navigate the complex regulatory landscape, ensure compliance across international markets, and drive continuous improvement in how labeling is developed, tracked, and delivered.

As a Senior / Consultant, Regulatory Labeling, you will partner with Label Strategist to :

  • Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
  • Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
  • Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
  • Utilize regulatory / product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.

You will also :

  • Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local / regional labeling (USPI, Med Guide, SmPC, PIL, Canadian Product Monograph, Instructions for Use) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
  • Act as operational expert for Global Labeling tracking in RIMs, SPL generation, ensure development and maintenance of templates, collaboration features and system upgrades.
  • Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation.
  • Support labeling inspection / audit readiness activities.

    • Demonstrates the use of the organization's consulting models and methodologies and uses experience to suggest possible developments / improvements.

    Business Development :

  • Maintain and continue to grow a network of industry colleagues through relationships formed during project engagements or through other industry experience.
  • Actively participates in project scoping calls and proposal preparation.
  • May deliver sales presentations and participate in bid defense meetings when needed.
  • Contributes information to support the account planning process and integrated marketing programs.
  • Contributes ideas for approaches to new clients or new service offerings.

    • Parexel-related Responsibilities :

  • Meets established metrics as specified in scorecard on an annual basis.
  • Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives / projects or as a mentor as requested by management.
  • Defines self-development activities to keep current within the industry (i.e. maintain membership in a relevant industry and / or scientific / technical association).
  • May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and / or author articles.)

    • Skills :

  • Strong attention to detail
  • Solid understanding and interpretation of EU / US labeling regulatory requirements
  • Solid understanding of requirements for tracking of labeling updates
  • Solid understanding of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice
  • Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency in MS Office suite; Willing to learn additional applications
  • Understanding of label development and submission processes preferred.
  • Ability to recognize and escalate issues
  • Strong written and oral communication and organizational skills
  • Ability to generate and initiate problem solving innovative solutions
  • The ideal candidate should be action-oriented, customer focused, ability to manage workloads and set priorities. In addition, he / she should be capable of dealing with ambiguity, be creative, and be comfortable working with multifunctional teams
  • High-level consulting skills
  • Critical thinking and problem-solving skills

    • Knowledge and Experience :

  • Good working knowledge of key labeling regulations / guidance and past experience in label development (CCDS, USPI, packaging)
  • Strong experience with EU labeling regulations is essential and US labeling experience is highly desired
  • The ability to research and create comparator labeling documents
  • Strong understanding and past experience creating annual reports
  • The ability to collaborate with Tech Ops for artwork implementation
  • Proficiency in SPL (all aspects, types and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
  • Electronic document management systems use and / or electronic submission experience
  • Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

    • Education :

  • Bachelor's Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies / packaging, supply chain regulatory affairs, or quality.
  • Exceptional candidates with 3+ years of labeling related experience may also be considered

    • If you thrive in fast-paced, high-stakes environments and love the idea of being a key player in a global regulatory roleapply today!

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