Senior Regulatory Affairs Labeling Specialist (Product Information)

January 10, 2019 | Lexington, MA (USA) | Quality Assurance and Regulatory Compliance

Scope:

Creates and updates labeling documentation and product information for an assigned group of pharmaceutical or medical products, in order to optimize patient safety and minimize product liability risk. Works internally with regulatory, clinical, quality and other internal functional areas and with external regulatory agencies to ensure timely regulatory and quality compliance, and to support business objectives as required.

Responsibilities:

  • Plans and manages projects, scope, deliverables and timelines using project management tools, managing communication with stakeholders (Legal, Marketing, Regulatory and QA) and leading the labeling portion of the project teams to keep deliverables aligned with business objectives and priorities. Ensures deliverables are met on-schedule.
  • Responsible for reporting project development into project teams on the status of labels.
  • Generate global and country-specific labeling requirements and specifications from design inputs, brand guidelines, and production procedures to ensure regulatory, quality, and commercial compliance. 
  • Analyze and evaluate the impact of proposed labeling changes; ensure appropriate revision control and proof-reading activities are executed in a timely manner; communicate change plans effectively to drive cross-functional alignment and approval. 
  • Demonstrate independence and a proactive ability to streamline existing processes and, as new compliance initiatives emerge, participate in the drafting and review of applicable Standard Operating Procedures (SOP) toward a lean labeling process.
  • Lead project team activities including, labeling implementation, schedules with key milestones, defining each functional area’s deliverables, communicating plans, schedules and changes and generating consensus from the team.
  • Identify project risks and mitigation plans related to labelling.
  • Contribute to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. 
  • Manage multiple labeling projects with minimal supervision; plan, schedule, coordinate, and track labeling deliverables (and their dependencies) to ensure labeling is completed on time, as planned.
  • Ensure that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.
  • Works with other functions to identify and resolve labeling inconsistencies with labeling material and requirements. This includes external partners.
  • Monitor, evaluate and recommend improvements to the label development process, systems tools and/or policies.
  • Actively participate in document control and the change management process to release compliant labeling.
  • Serve as a technical resource for in-house customers who utilize labeling and collaborate with cross-functional partners who support the labeling process from development to production.

Education / Experience:

  • Bachelor’s degree with 5-7 years of relevant experience.
  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  • Practical knowledge of Project Management including experience managing complex projects with cross-functional teams.
  • Knowledge with utilizing computer-aided design equipment and/or graphic tools such as, CAD, Adobe Illustrator/Photoshop and other related software, Experience working with project management tools, adobe acrobat pro, MS Office Tools, and ERP systems.
  • Knowledge of labeling workflow from creation to obsolescence.
  • Knowledge of FDA, GMP, IVD, and ISO requirements and guidelines.
  • Experience developing artworks, graphics, and electronic publications, for regulated medical products.
  • Experience with regulations, translations and standards relating to labeling in IVD, Medical Device, Pharmaceutical or related industry

Skills / Pre-requisites:

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Requires ability to be innovative, resourceful, and work with minimal direction.
  • Strong proofreading skills and meticulous attention to detail.
  • Requires excellent organization, prioritization, and problem-solving skills.
  • Knowledge of IVDR.
  • Travel up to ~25%

Sekisui Diagnostics is a global company that understands the value of their employees. You will be part of a team that is built on strong core values. Sekisui Diagnostics offers a competitive salary, a competitive benefits package, and opportunities for professional growth to help you develop your skills to be successful in your career.

Thank you for your interest in this position. Only those Applicants selected for an interview will be contacted.

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