Teva Pharmaceuticals Regulatory Affairs Associate I Job Vacancies for B Pharmacy /M Pharmacy / Master of Life Sciences – M Pharm preferred
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 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
- Qualifications
Qualifications: B Pharmacy / M Pharmacy / Master of Life Sciences – 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
Qualifications: B Pharmcy / M Pharmacy / Master of Life Sciences – M Pharm preferred
Experience: Total years of experience required for the role: 2-4 years (preferred – Regulatory Publishing experience in EU and US market)
