Associate Director, Strategic Global Labeling
Posted on Apr 6, 2021 by Mallinckrodt Pharmaceuticals
The Associate Director (AD), Strategic Global Labeling (SGL) serves as the regulatory contact for labeling on the global Regulatory Affairs (RA) sub team to ensure that labeling requirements are met for new and life-cycle products. Additionally, he/she is responsible for the development and maintenance of Company Core Data Sheets (CCDS), Prescribing Information and Patient Package Inserts, across multiple therapeutic areas in line with international standards and guidelines.
The AD will work independently across Regulatory Affairs. Plans and executes review of safety and non-safety related labeling changes. Demonstrates thorough understanding of applicable global regulations and effectively communicates same. Collaborates in the development of labeling within the Labeling Working Group (LWG), Labeling Review Committee (LRC) and related teams/committees and provides thorough and concise briefings for line management.
The AD may interact with global regulatory authorities. Effectively leads interdisciplinary teams.
Proactively participate in the strategic optimization of labeling documents via close scrutiny of company data, regulatory precedents and trends and competitor labeling.
Provide regulatory strategy and oversight of global labeling for assigned commercial products and development products.
Provide guidance to launch teams on launch strategy for new commercial products.
Lead label development, revision, review, approval and maintenance in compliance with CCDS, local requirements, business strategies, and overall quality.
Lead the Labeling Working Group (LWG) and Labeling Review Committee (LRC) to optimize label documents and promote cross-functional understanding of labeling dependencies.
Develop presentations to insure the information presented is suited to audience and desired outcomes.
Ensure the dissemination of LRC-approved labeling documents and supporting documentation; ensure quality of labeling deliverables (eg, alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
Contribute to the development of labeling processes.
Participate in any relevant continuous improvement efforts for labeling process.
Proactively participate in the implementation of the global labeling strategy including the development of target product labeling (TPL) for assigned products.
Bachelor degree; advanced degree strongly preferred.
Eight (8) plus years drug/device development experience with three (3) years of experience in regulatory activities.
RAC certification desirable.
Experience leading teams.
Experience in developing and giving presentations
Mastery level knowledge of FDA guidelines and regulations with an emphasis on labeling activities.
Significant knowledge of global standards and regulations related to New Drug Applications, CCDS, and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
Thorough understanding of scientific principles and regulatory/quality systems relevant to drug development.
Models, inspires, and creates conditions for a respectful, highly ethical, and open work environment.
Excellent verbal and written communication skills as well as strong interpersonal skillsOp.
Ability to prioritize, manage multiple projects and meet project timelines
Ability to determine essential components of requirements in order to include them in applicable policies and procedures.
Demonstrates understanding of influencing others and is able to successfully negotiate solutions.
Ability to develop creative solutions to complex problems.
Excellent verbal and written communication skills as well as strong interpersonal skills
High attention to detail
Work effectively with minimal supervision