Insmed Incorporated

Associate Director, Regulatory Labeling

ID
2020-1316
Job Function
Regulatory Affairs

Company Description

About Insmed!

 

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

Overview

About the Role!

 

This is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed and developmental products.

  • This is a non-supervisory position
  • This role may oversee vendors and/or contractors

Responsibilities

In close collaboration with Regulatory project leaders in US/EU/Japan, RA Labeling will be responsible for

  • creation and/or updates to and internal review and approval process of:
    • CCDS
    • prescribing information (US PI, SmPC)
    • medication guide
    • patient information/leaflet/IFU for development products for all regions
  • updating and internal review and approval process for post-approval labeling changes of the above for marketed products

RA Labeling will also be responsible for all packaging labeling

RA Labeling will be responsible for coordinating with Supply Chain multidiscipline team for implementation strategy

RA Labeling oversee the maintenance, archive, and control of all labels utilizing label and artwork management software

 

In general, RA Labeling will:

  • ensure labeling is compliant with regulations, guidances and in line with internal SOPs for consistency across all Insmed labels.
  • assess new regulations for impact on Insmed products.
  • create, revise, maintain labeling and artwork SOPs.
  • be the primary contact with vendors (e.g., translation services) as needed.
  • represent labeling group on product sub teams, when applicable.
  • participate in labeling meetings with Health Authorities as necessary.
  • develop project timelines and responsible for managing labeling projects from initiation to completion.
  • Manage all artwork communications to both internal stakeholders and external vendors.
  • Make key decisions on delivery dates, artwork development path while managing cross-functional team deadlines.

Qualifications

About You!

 

  • Bachelor’s degree; advanced degree preferred
  • 3+ years of pharmaceutical industry experience, including 2-4 years in regulatory/labeling
  • Full understanding of the drug development process
  • Knowledge of FDA regulations and guidances
  • Experience with BLUE (or equivalent labeling management) Software
  • Proficient in MS Office applications
  • Ability to analyze and solve problems
  • Excellent communications skills
  • Excellent organizational and time management skills to manage multiple ongoing projects simultaneously

Additional Information

Travel Requirements:

  • Domestic and/or International travel required - 5%.
  • Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
  • Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
  • Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.

 

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