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US Labeling Regulatory Affairs Manager

US Labeling Regulatory Affairs Manager

Teva PharmaceuticalsBengaluru, Republic Of India, IN
20 days ago
Job description

The Opportunity :

  • The Senior Manager is responsible for setting strategic goals, managing, leading and developing teams, driving operational efficiency, and making high-level decisions that affect the teams success. In addition, will be responsible for the supervision, critical review, & approval of established US Gx labeling documents filed under an ANDA / 505(b)2s while adhering to federal regulations, internal processes, & meeting timelines driven by company goals. Additionally, the Sr. Manager will oversee any / all team databases and trackers.
  • The candidate must possess a firm knowledge of FDA US labeling regulations & guidance for products filed under an ANDA / 505(b)2 and should be a SME in all facets of US labeling, including, but not limited to SPL, PADERs, and AR compilation.
  • Finally, candidate will be responsible for ensuring all required FDA reporting obligations are met in accordance with business objectives & regulations maintaining 100% compliance.

Roles & Responsibilities :

  • Responsible for establishing and effectively implementing labeling strategies associated with the development and maintenance of labeling for all US generic product ANDAs / 505(b)2s, (pre and post-approval).
  • Assures that all required FDA reporting obligations are met in accordance with established business objective and regulations.
  • Provides guidance and leadership regarding best practices in the labeling arena.
  • Hands on leader in regard to daily workload
  • SME in the development, review, & electronic compilation of labeling documents to align with the RLD, FDA solicited safety changes, company initiatives, & submission requirements for assigned ANDAs / 505(b)(2)s per internal processes & prior to final disposition.
  • Responsible for assigning labeling projects.
  • Oversee the maintenance of the labeling trackers ensuring all assigned projects remain on track.
  • SME in Structured Product Labeling (SPL) ensuring alignment with applicable FDA regulations & guidance’s.
  • Work closely with Regulatory Operations to ensure assigned projects are submitted on-time following the eCTD requirements related to labeling.
  • Work closely with external departments to align with product / device strategy impacting pre and post approval portfolio.
  • Attend meetings relevant to area of responsibility.
  • Create, revise, and / or train on SOPs / WIs, as appropriate.
  • Maintain a metric of all team projects for reporting purposes.
  • Maintain knowledge of US regulations, guidelines, & SOPs / WIs applicable to US Gx labeling.
  • Experience in developing labeling content that requires carve outs due to protected language associated with patent / exclusivities is preferred.
  • Performs all other job related duties as required by management.

    • Qualification & Experience :

  • M Pharm / B Pharm with a Scientific or Regulatory background or equivalent combination of education and experience
  • Total years of experience required for the role : Minimum 8 years of US labeling experience and at least 3 years supervisory experience preferred
  • Relevant years of experience : Minimum 8 years Pharmaceutical industry experience required, specifically in Regulatory Affairs & US ANDA / 505(b)(2) labeling
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    Manager • Bengaluru, Republic Of India, IN

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