Teva Pharmaceuticals Hiring 2022 Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience for Regulatory Affairs Associate I – US Labeling At Navi Mumbai, IN . Teva Pharmaceuticals Notification full details below..Interested and eligible candidates can Apply Now.
- Vacancy details:
- Post Name: Regulatory Affairs Associate I – US Labeling
- Qualification: Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience
- Experienced:Total years of experience required for the role: 1-2 years Relevant years of experience: 1-2 years (1-2 years of pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US labeling as well as proofreading manually and with Electronic Proofreading Systems)
Job Description: Teva Pharmaceuticals Hiring For Regulatory Affairs Associate I – US Labeling !
- Important Details :
- Location: Navi Mumbai, IN
- Post of date:02/08/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
- Develop labeling documents to ensure alignment with the Reference Listing Drug. This includes QC, proofing, editing and formatting of documents, and coordinating the review and approval of final submission documents with US Labeling Team members.
- Create, revise, and prepare labeling documents needed for full responses to FDA via appropriate filing mode. This includes but is not limited to development of content of labeling, side-by-side comparisons and other required submission materials, as necessary.
- Work within the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool TVT.
- Work with US Regulatory Labeling Team to ensure assigned projects like RLD updates, Safety labeling changes, Annual reportable changes, Electronic Medication Guide initiatives etc. and any other projects, as per requirement, are submitted on-time following the eCTD requirements related to labeling.
- Maintain an accurate and current team tracker in order to identify and monitor all labeling projects ensuring timelines are met.
- Provide regular project status check-ins, progress tracking, and updates on deliverables with internal team members, as applicable.
- Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling.
- Performs all other job related duties as required by management.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
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