B Pharma & M Pharma Regulatory Affairs Associate Vacancy @ Teva
Teva hiring Submission Publishing Regulatory Affairs Associate. B Pharma & M Pharma job opening 2022, Pharmacy job opening 2022, Pharma job opening 2022. Regulatory associate job opening 2022. Pharmacy job opening 2022. Candidates with bachelor’s and master’s degree in pharmacy may apply for the job opening at Teva. Check out all the details on the same below:
Job Title: Regulatory Affairs Associate I – Submission Publishing
Function Regulatory Affairs
Sub Function Medical Regulatory Affairs
Location: Navi Mumbai, IN, 400706
Elibiglity Criteria B. Pharm/M. Pharm – M Pharm preferred
Experience:
Total years of experience required for the role: 2-4 years (preferred – Regulatory Publishing experience in EU and US market)
Knowledge and skills
Command over spoken and written English
Sensitivity to the cultural diversity of a global organization
Job Description
- Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US, and Canada.
- Exposure in handling initial submissions publishing and transmitting quality submissions to the agency.
- Perform document-level publishing activities, troubleshoot document issues, and perform quality control checks for submission-ready documents as per the agency guidance.
- Collaborate with scientific personnel for planning, preparation, publishing, and quality control checks of submissions.
- Hands-on expertise in EU and US submissions from pre-approval to post-approval activities like initial, variations, PSUR, etc.
- Participate in Global Regulatory Affairs project teams
- Maintain working knowledge of internal and external publishing standards.
- Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
- Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator
- Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems
Click Here To Apply Online
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