Mgr Regulatory Affairs, Labeling

Who we are

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 & guidances 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.

How you’ll spend your day

• 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.

Your experience and qualifications

• MPharm/BPharm 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

Teva’s Equal Employment Opportunity Commitment