Regulatory Affairs Recruitment @Teva – Pharma Candidates Apply
Teva invites postgraduate chemistry candidates for the post of pharma regulatory affairs. Teva announces a job opening for postgraduate Pharma candidates. Pharma job opening 2021. Pharma job opening 2021. Check out all the details on our website Rasayanika.com
Job Title: Regulatory Affairs Associate II – Submission Publishing
- 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 for self as well as peers.
Hands-on expertise in EU 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.
Act as backup and support to group leader in his/her responsibilities
- Taking responsibility and initiative in upcoming projects and forecast the challenges
Plan the trainings/knowledge sharing sessions which helps team to develop their skills
B. Pharm/M. Pharm/ Master of Life Sciences – M Pharm preferred
Total years of experience required for the role: 4-6 years (preferred – Regulatory Publishing experience in EU and US market)
Knowledge and skills:
- Proven leadership capabilities and strategic thinking, strong interpersonal skills including troubleshooting of errors while publishing, exceptional analytical skills, strong multi-cultural skills, high energy level
- Command over spoken and written English
- Sensitivity to the cultural diversity of a global organization
Function Regulatory Affairs
Sub Function Medical Regulatory Affairs
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