Sr Manager Regulatory Affairs - US Labeling

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