The Regulatory affairs job position at Teva Pharmaceuticals in Bangalore, India, offers an exciting opportunity to contribute to the company’s mission of making good health more affordable and accessible worldwide. Teva Pharmaceuticals is a global leader in the manufacturing of generic medicines and takes pride in producing numerous products listed on the World Health Organization’s Essential Medicines List. With a presence in nearly 60 countries, the company fosters a diverse and inclusive environment that brings together individuals from various nationalities and backgrounds. As a Regulatory Affairs Associate II, you will play a crucial role in ensuring the quality and timely submission of regulatory activities.
Regulatory Affairs Associate II – 1435
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job Id: 49832
Qualifications: B. Pharm/M. Pharm/ Master of Life Sciences.
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
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
Experience needed for Regulatory affairs associate job : 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
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Here are a few interview questions and possible answers for the Regulatory affairs job role :
1. Can you tell us about your experience in regulatory publishing, specifically in the EU and US markets?
Answer: I have been working in the regulatory affairs field for X years, with a focus on publishing activities. During my experience, I have successfully handled major and complex routine/lifecycle management eCTD submissions for both EU and US markets. I am well-versed in the submission requirements and guidelines of these regions, including initial submissions, variations, and post-approval activities.
2. How do you ensure the quality and timeline of regulatory submissions?
Answer: To ensure quality and timely submissions, I meticulously perform document-level publishing activities, troubleshoot document issues, and conduct quality control checks. I follow agency guidance and maintain a comprehensive understanding of internal and external publishing standards. Additionally, I collaborate closely with scientific personnel to plan, prepare, and conduct quality control checks for submissions.
3. Can you describe your experience with regulatory strategy and its importance in the role?
Answer: While my primary focus has been on publishing, I have developed a basic understanding of regulatory strategy. I believe that regulatory strategy plays a crucial role in determining the path to successful regulatory submissions. By aligning regulatory activities with business goals and market requirements, we can optimize the chances of approval and ensure compliance with regulatory guidelines.
4. How do you handle complex problems or challenges that arise during the publishing process?
Answer: When faced with complex problems or challenges, I approach them with a creative problem-solving mindset while staying within the parameters of good practice. I analyze the situation, gather relevant information, and generate unique yet practical solutions. By leveraging my expertise and collaborating with cross-functional teams, I find workable and useful resolutions to difficult problems.
5. How do you stay updated with the latest regulatory guidelines and publishing standards?
Answer: I proactively maintain my knowledge of the latest regulatory guidelines and publishing standards by continuously monitoring industry updates, attending relevant training sessions, and actively participating in professional networks. I also keep myself informed about advancements in technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, and Lorenz/EURS validator to ensure efficient publishing practices.
ALL THE BEST !
