What are the responsibilities and job description for the Regulatory Affairs Associate II, Labeling position at Teva Pharmaceuticals?
Regulatory Affairs Associate II, Labeling
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Job Description
Position Summary
The Regulatory Affairs Associate II, Labeling is responsible for the generation, revision, submission of pre & post approval NDA 505(b)(2), while ensuring adherence to federal regulations and meeting deadlines driven by company goals.
In addition, assists, when needed, in the generation, revision, submission of pre & post approval generic labeling filed under an ANDA while adhereing to federal regulations & internal processes & meeting deadlines driven by company goals.
The candidate will be required to work with minimum supervision and possess a strong knowledge of FDA US labeling regulations surrounding NDA 505(b)(2)s & ANDAs, as well as FDA guidances to the level of applying them effectively to all work output in addition to developing compliant Structured Product Labeling (SPLs) files with complete drug listing information.
Travel Requirements: Minimum Local/Domestic travel
- Develop and electronically compile labeling documents to align with company goals and submission requirements for assigned NDA 505b2s and ensure labeling meets all legal and regulatory requirements. At times assist, when needed, in the generation, revision, submission of pre & post approval generic labeling filed under an ANDA. This includes QC, proofing, editing and formatting of documents, and coordinating the review and approval of final submission documents.
- Work with management to handle Generic Product Working Group (gPWG) meetings (per SOP) with appropriate stakeholders when establishing/revising labeling for NDA 505b2 applications, and at times for complex device/combination products.
- Some experience in developing labeling content that requires carve outs due to protected language associated with patent/exclusivities.
- Establish SPL for assigned projects. Ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDA’s Electronic Submission Gateway.
- Create, revise, and prepare labeling documents needed for full responses to FDA via appropriate filing mode. This includes, but is not limited to, develpment of side-by-side comparisons, SPL, and other required submission materials, as necessary.
- Perform quality reviews of labeling and submission documents.
- Work closely with external departments, including CMC team(s) and device team(s), to align with internal product/device strategy.
- Work with Regulatory Operations to ensure assigned projects are submitted on-time following the eCTD requirements related to labeling.
- Attend assigned project meetings to ensure labeling timelines are met.
- Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation and completion of projects.
- Maintain knowledge of regulations, guidelines, and standard operating procedures applicable to Gx labeling.
- Work in a team environment with minimum supervision.
- Performs all other job related duties as required by management.
Qualifications
- BA with a Scientific or Regulatory background or equivalent combination of education and experience in the US labeling field.
- 3 years pharmaceutical industry experience, specifically in Regulatory Affairs, with a focus on NDA 505b2 labeling.
- Knowledge of SPL development and FDA drug listing requirements.
- Have exemplary oral and written communication skills
- Be organized with a keen attention to detail
- Have the ability to work independently, as well as in a team environment, with minimum supervision
- Have knowledge of FDA US regulations and guidances related to US Gx labeling (505b2s & ANDAs)
- Have knowledge of FDA eCTD submission
- Demonstrates the ability to establish and maintain good working relationships within company and with external contacts.
- PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
- Adobe Acrobat Professional
- Familiarity with TVT and Intagras SPL portal preferred
Function
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Salary : $63,400 - $80,300
