Regulatory

  • location: Lexington, MA
  • type: Permanent
  • salary: $95,000 - $130,000 per year

description

Chat with me now! - https://flashrecruit.com/jobs/296720

Regulatory Labeling Ops Manager

Skill Set

  • Ideal candidate would have prior Regulatory Labeling Operations experience, preferably with a knowledge of US labeling requirements for medical devices.
  • As this is quite a niche role we would also consider candidates with a background in Artwork, or Packaging Technology concentrating on US experience.
  • 5+ years of experience in industry
  • Will not provide relocation
  • Range is $95-130k

Job Responsibilities

  • Provide a support function to the RA product leads with prime responsibility for US products.
  • Subject Matter Expert (SME) for all matters relating to US product labeling artwork
  • Work with the Supply Chain team to help manage the packaging update process following approval, including progression of artwork via Shire's Artwork Management system (SAMs).
  • Review new packaging, primarily for US products, and complete all steps required to implement the packaging.
  • Regulatory assessment of changes impacting US artwork.
  • Assist with authoring and review Shire Standard Operating Procedures, Best Business Practices.
  • Assist with EU changes impacting labeling including progression of artwork via SAMs.
  • Maintain compliance of approved texts and approved packaging.

50% of Responsibilities

  • Development, review and approval of labeling artwork for all approved products for US. Liaison with US Strategy Product Leads/Specialists on product updates impacting labeling.
  • Attendance at meetings with US supply chain logistics.
  • Attendance at meetings for US new product launches (as required by US Strategy Product Leads/Specialists).

20% of Responsibilities

  • Assist with EU submissions impacting labeling.

10% of Responsibilities

  • Author and review Shire's standard operating procedures and associated documents relating to artwork/regulatory involvement with Supply Chain.
  • Dispatching revised product labeling to the different departments inside and outside of Regulatory (as appropriate with local requirements.)
  • Training and advice to functions on US labeling requirements, including updating relevant functions on changes to US labeling legislation.

Education & Qualifications

  • At least 5-8 years experience in the pharmaceutical industry, specifically in Supply Chain, Regulatory or Packaging Design.
  • Expertise in US packaging regulations, with emphasis on Biologics.
  • Knowledge of EU packaging regulations.
  • Awareness of the print industry and manufacturing techniques and how they impact packaging design.
  • Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/296720

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