1+ months

Senior Regulatory Affairs Labeling Associate

Frazer, PA 15084
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description

The Regulatory Affairs Labeling Associate III is a tactical role within Global Branded Products Regulatory Affairs (GBP RA) and is generally responsible for creating routine labeling documents in support of regulatory submissions, managing labeling artwork creation, tracking labeling implementation, completing structured product labeling and drug listing submissions, and labeling sections of routine reports (PADER, Annual Report). The associate will support the regulatory strategy teams in scheduling and managing labeling creation and revision, including submission documents, for products in the Respiratory, Oncology, Internal Medicine and Womens Health therapeutic areas. 

Essential Duties & Responsibilities 


1. Labeling Implementation: Creates and distributes mark-up labeling documents and artwork requests, works with artwork management team to create and approve artwork for labeling components. Tracks labeling implementation activities. Proofread labeling documents for accuracy and compliance with regulations. Provides labeling documents for FDA submissions. Reviews and approves labeling components in Veeva. Maintains current and historical labeling activity history files (SharePoint and EDMS-based).  
2. Structured Product Labeling: Creates, updates and submits Structured Product Labeling (SPL) content of labeling and drug listing files for marketed products and regulatory applications. Ensures labeling content and drug listing data elements are maintained as current for marketed products.   
3. Periodic Reporting: Completes labeling sections for periodic reporting (PADERs and Annual Reports). Supplies current labeling components for reports.  
4. Supports process improvements within the labeling function (labeling history tracking tool, document storage consolidation). 
5. Follows Teva Safety, Health, and Environmental policies and procedures. 
6. Other duties as assigned or as business needs require 


Primary Outcomes


1. Initiate and track to completion all labeling implementation activities. Maintain structured product labeling for branded products. Maintain labeling history records.
2. Complete periodic reporting labeling sections. Provide labeling documents for FDA submissions.


Position Requirements

Education Required: Bachelors Degree in scientific field or equavalent labeling experience.
Education Preferred Graduate training in science, Regulatory Affairs and/or Drug Development
Experience Required: Minimum of 3 year in the pharmaceutical industry (or equivalent education or experience), with at least one year in a Regulatory Affairs role. Working knowledge of FDA regulations and guidances.
Experience Preferred: 5 years of pharmaceutical industry experience in new drug regulated product submissions; including working knowledge of FDA labeling regulations, directives and guidances.
Functional Knowledge: Understanding of the regulatory application process, preferably with submissions experience.
Company/Industry Related Knowledge: Working knowledge of the drug product development process, including FDA regulations.

Regulatory Affairs
Sub Function
Medical Regulatory Affairs
Reports To
In process of validation
Tevas Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Posted: 2019-10-10 Expires: 2019-11-23

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Regulatory Affairs Labeling Associate

Teva Pharmaceuticals
Frazer, PA 15084

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