24 days old

Manager, Regulatory Labeling

Alnylam Pharmaceuticals
Cambridge, MA 02139
  • Job Code
    200293

Manager, Regulatory Affairs, Global Labeling Operations

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

In this newly created position reporting to the Associate Director of Regulatory Affairs for Global Labeling Strategy, the Manager of Global Labeling Operations will assist in building and refining Alnylam's global labeling processes and capabilities and will provide labeling operational support.

Summary of Key Responsibilities

  • Manage end-to-end labeling process and tracking activities, proactively identifying risks, issues and solutions to challenges, to ensure approved content is implemented globally per applicable laws, regulations, and company policies and SOPs.
  • Act as Subject Matter Expert (SME) responsible for providing guidance on artwork labeling requirements, labeling change control, and E2E tracking activities.
  • Support creation and maintenance of SOPs, Work Instructions, Job Aids and User Guides describing labeling processes and best practices to ensure global compliance.
  • Represent Global Labeling Operations on product-specific global labeling implementation teams and other cross-functional product teams as appropriate. Provide guidance on upcoming labeling changes and implementation timelines.
  • Collaborate closely with Labeling Strategy, Regulatory Strategy, Quality, Supply Chain, Commercial, and other stakeholders to lead development and updating of assigned products artwork, mockups.
  • Collaborate with appropriate stakeholders for management of linguistic reviews and labeling translations.
  • Responsible for labeling change control impact assessment and tracking activities.
  • Approve artwork for packaging components.
  • Partner with Regulatory Technology and Operations, and Supply Chain, to ensure submission-ready labeling components comply with regulatory requirements. Assist with preparation of submissions to health authorities, as needed.
  • Assist with document lifecycling within eDMS, as needed.
  • Support the growth of the Global Labeling function and help design/build systems and processes.

Qualifications
  • Bachelor's or Masters' degree with a .
  • A minimum of 3 years of relevant Regulatory, Labeling, Packaging, Project Management and/or Quality work experience in the biopharmaceutical industry.
  • Familiarity with US, EU and Global regulations, standards and guidance documents related to labeling of pharmaceutical products.
  • Excellent interpersonal skills; ability to work well independently as well as in a team environment.
  • Excellent written and verbal communication skills, including negotiation skills.
  • Excellent organizational and project management skills; must be detail-oriented with demonstrated ability in managing multiple projects.
  • Ability to work effectively with colleagues in other departments and at all levels and with CROs and external consultants.
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.
  • Familiarity with VEEVA Submissions and Quality Modules, global labeling artwork management system(s), and SPL preferred .

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.





Posted: 2021-02-09 Expires: 2021-03-10
Sponsored by:
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Manager, Regulatory Labeling

Alnylam Pharmaceuticals
Cambridge, MA 02139

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