Manager/Senior Manager, US Labeling Regulatory Operations, Commercial Regulatory Affairs

Location
Cambridge, MA, United States
Posted
Jul 18, 2021
Ref
R-07753
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Manager/Senior Manager, US Labeling Regulatory Operations, Commercial Regulatory Affairs

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Do you have regulatory affairs labeling experience and looking for an opportunity to drive and lead projects?

As Manager/Sr. Manager, US Labeling Operations you will provide regulatory support for US labeling projects. Under the direction of commercial regulatory leadership, you will review and revise draft labels, create and modify Structured Product Labeling, implement label into packaging and artworks, track and archive labeling for US products and complete electronic drug listing. You will also be responsible for some ancillary regulatory operations tasks for the US affiliate.

Your role will involve:
  • Providing Regulatory support in the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes. Utilizing Software to ensure a QC match of commercial product labeling to the FDA approved label.
  • Managing the development of the SPL version and posting on Daily Med. Initiating implementation of labeling into packaging and artworks.
  • Tracking all label changes in the labeling tracker maintaining labeling documents throughout the product lifecycle
  • Assisting with maintenance of controlled records for historical labeling changes and communicate labeling changes to stakeholders at the time of implementation
  • As needed, you will also support the implementation of process improvement changes to increase the efficiency and effectiveness of US labeling processes interacting with Regulatory Affairs colleagues and cross-functionally with global members of the Clinical, Medical, Legal, Safety, Commercial, Quality and Supply Chain organizations to support the use and development of current and new tools, technologies and processes fostering efficient global label development and worldwide submissions and approvals
  • Staying up to date with the US regulation changes and FDA Guidance pertaining to Labeling regulations and maintain the US labeling SOP and work instructions.
  • Completing electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents
  • Identifying changes needed for FDA- approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements
  • Completing tasks supporting regulatory operations such as: coordinate payment of annual invoice for PDUFA user fees and liaising with publishing to complete FDA submissions seeking advisory comments


In return, you will bring:
  • BA/BS degree required ideally in a life science field
  • Strong expert knowledge of regulations, guidance and strategies to optimize labels during development and life-cycle management of products is required
  • Experience with driving and leading projects, excellent stakeholder management skills are required
  • Between 2-5 years US regulatory affairs labeling experience
  • Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments
  • Experience with proofreading technical documents
  • Level to be determined based on qualifications relevant to the role


If this sounds like an exciting opportunity to apply your labeling experience on our US commercial regulatory team, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.