Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.
Post: Regulatory Affairs Associate II
The opportunity
Regulatory Affairs associate II – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate
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 for self as well as peers.
- Hands on expertise in EU submissions from pre-approval to post approval activities like initial, variations, PSUR etc.
- Basic understanding of regulatory strategy
- 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, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz/EURS 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.
- Proactively participate in upcoming projects and provide inputs wherever necessary
- Plan the trainings/knowledge sharing sessions which helps junior team members to understand the process
- Act as buddy for new joiners
- Risk/benefit analysis skills
Candidate Profile
- B.Pharm / M.Pharm / Master of Life Sciences.
- Total years of experience required for the role: 4-7 years (preferred – Regulatory Publishing experience in EU and US market)
- Strategic thinking, strong interpersonal skills including troubleshooting of errors while publishing, strong analytical skills, strong multi-cultural skills, high energy level
- Command over spoken and written English
- Sensitivity to the cultural diversity of a global organization
Additional Information
Experience: 4-7 years
Qualification: B.Pharm / M.Pharm / Master of Life Sciences
Location: Bangalore
Industry Type: Pharma
Functional Area: Regulatory Affairs
End Date: 30th July, 2023
