The opportunity
The Manager is responsible for the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)(2) by US and Mumbai/Bangalore (India locations) members while adhering to federal regulations, internal processes, and meeting timelines driven by company goals. The Manager will also be responsible for their own assignments, when needed, and working closely with other Managers surrounding the review and approval of labeling documents established for these projects. Additionally, the Manager will oversee all team databases and trackers and will update them when changes are required.
The candidate must possess a firm knowledge of FDA US labeling regulations and guidances for products filed under an ANDA/505(b)(2). They should be a Subject Matter Expert (SME) in all facets of US labeling, including, but not limited to, SPL, PADERs, and AR compilation, in order to provide direction to direct reports.
Finally, the candidate will be responsible for ensuring all required FDA reporting obligations are met in accordance with business objectives and regulations, maintaining compliance.
How you’ll spend your day
Hands-on leader in regard to daily workload; in addition to managerial responsibilities, this position could have independent work assignments to manage, when needed, as well as participate in the preparation of labeling submission documents.
SME in the development, review, and electronic compilation of labeling documents to align with the RLD, FDA-solicited safety changes, company goals, and submission requirements for assigned ANDAs/505(b)(2)s per internal processes and prior to final disposition.
Responsible for ensuring projects are assigned to direct reports and/or external team members in the US and Mumbai.
Communicate, plan, prioritize, and perform training to ensure labeling documents meet all legal and regulatory requirements.
Maintain the labeling tracker, ensuring all assigned projects remain on track by direct reports.
SME in the development/review of Structured Product Labeling (SPL) documents (content and data elements) ensuring alignment with applicable FDA regulations and guidances.
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 the approved portfolio.
Attend meetings relevant to the area of responsibility.
Train and develop respective team members in the US and Mumbai.
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, and SOPs/WIs applicable to US Gx labeling.
Experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities is preferred.
Perform all other job-related duties as required by management.
