Job Summary
The Senior Manager/Associate Director, Global Regulatory Affairs (GRA) Labeling, reporting to the Head of GRA Labeling, is responsible for leading the development and execution of global labeling content and strategies across a portfolio of products at various stages of development. This includes managing updates or creation of Company Core Data Sheet (CCDS), U.S. Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), Canada Product Monograph (PM), and other local labeling documents, as needed.
As the labeling expert on the Global Regulatory Team, this role provides strategic and operational insight, in partnership with Global and Regional Regulatory Leads, ensuring labeling is scientifically accurate, regulatory-compliant, and aligned with the company position. The role also manages labeling deviations.
In addition to core responsibilities, the role may support labeling process optimization initiatives aimed at enhancing efficiency and quality. Collaboration with external partners may also be required.
Key responsibilities
- Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards.
- Author new and/or revised CCDS, USPI and EU SmPC for assigned products, obtaining input and approval from all relevant functional areas.
- Conduct research on labeling precedent, regulatory policies, and health authority requests, to advise on potential labeling impact, strategy, or outcome.
- Provide strategic input for Health Authority interactions related to labeling, including submissions, responses to questions, and negotiations.
- Manages process for alignment of local labeling with CCDS/reference label, including assessment of labeling deviations.
- Support local affiliates in responding to health authorities queries and reviewing local labeling differences.
- Act as the GRA Labeling point of contact on Global Regulatory Team to ensure timely delivery of compliant, high-quality labeling documents.
- In collaboration with Supply Chain, contribute to the development of new and updated packaging mock-ups and artwork for regulatory submissions.
- Actively contributes to improvement of labeling processes to enhance agility, efficiency, and accuracy.
Qualifications
- Bachelor’s degree in a scientific discipline. Advanced degree (MS, PharmD, PhD) preferred.
- Relevant experience in the pharmaceutical industry including 3+ years of direct experience in Regulatory Labeling.
- Experience that demonstrates ability to develop labeling documents.
- Ability to guide cross-functional teams and drive consensus to address labeling issues.
- Ability to assimilate clinical and scientific information and distill important aspects for impact to labeling. Understanding of medical concepts and terminology.
- Strong project management skills to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory labeling.
- In-depth and practical knowledge of labeling requirements globally (US and EU required), including development and life-cycle management of local labeling documents.
- Experience with document management systems (Veeva preferred).
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
