Teva Pharmaceuticals MSc Life Sciences Regulatory Affairs Associate Job, Apply Online
Job role: Regulatory Affairs Associate II – 1435
Company: Teva Pharmaceuticals
Job Id: 49832
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
How you’ll spend your day:
- 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
Your experience and qualifications
Qualifications: B. Pharm/M. Pharm/ Master of Life Sciences.
Experience: Total years of experience required for the role: 4-7 years (preferred – Regulatory Publishing experience in EU and US market)
Knowledge and skills:
- 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