Teva Pharmaceuticals MSc Life Sciences Regulatory Affairs Associate Job, Apply Online
Teva Pharmaceuticals MSc Life Sciences Regulatory Affairs Associate Job, Apply Online. MSc life sciences regulatory affairs associate job opening. Interested and eligible applicants can check out all of the details on the same below
Interview Questions and Answers for the Regulatory Affairs Associate II – RA Publishing position at Teva Pharmaceuticals are posted below
Job role: Regulatory Affairs Associate II – 1435
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Job Id: 49832
Who we are
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.
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 AssociateHow 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
Interview Questions and Answers for the Regulatory Affairs Associate II – RA Publishing position at Teva Pharmaceuticals:
1. Can you provide an overview of your experience in regulatory publishing and your understanding of its importance in ensuring submission quality and timelines? Answer: In my previous roles, I have actively participated in regulatory publishing activities, specifically focused on ensuring the quality and timely submission of regulatory documents. I understand that regulatory publishing plays a crucial role in compliance with regulatory guidelines and requirements. By effectively publishing and dispatching major routine/lifecycle management eCTD submissions for the EU, US, and Canada, I have developed a strong understanding of the importance of submission quality and adherence to timelines to support regulatory approvals and product launches.
2. How have you handled the challenges of handling initial submissions and transmitting high-quality submissions to regulatory agencies? Answer: Handling initial submissions can be complex, but I have experience in effectively managing this process. I ensure that all submission documents are meticulously prepared and undergo thorough quality control checks in accordance with agency guidance. By troubleshooting document issues and collaborating with scientific personnel, I have successfully transmitted high-quality submissions to regulatory agencies. My attention to detail and understanding of regulatory requirements have enabled me to overcome challenges and deliver accurate and compliant submissions.
3. Can you describe your approach to performing document level publishing activities and ensuring submission-ready documents? Answer: When performing document level publishing activities, I follow a systematic approach. I carefully review each document, ensuring its compliance with agency guidelines and specifications. I troubleshoot any issues that may arise, such as formatting or technical errors, and make the necessary adjustments to ensure submission readiness. Quality control checks are conducted to verify the accuracy, completeness, and integrity of the documents. This attention to detail and adherence to regulatory standards help me deliver submission-ready documents that meet the required quality standards.
4. How have you demonstrated your expertise in EU submissions from pre-approval to post-approval activities? Answer: I have a comprehensive understanding of the regulatory requirements and processes involved in EU submissions. I have hands-on experience in preparing submissions for pre-approval activities, including initial submissions, variations, and PSURs. Throughout my career, I have consistently stayed updated on the latest regulatory guidelines and requirements specific to the EU market. This expertise allows me to navigate the complexities of EU submissions and ensure compliance throughout the entire lifecycle of a product.
5. Can you provide an example of a difficult problem you encountered during regulatory publishing and how you approached finding a solution? Answer: In a previous project, we encountered technical challenges with the eCTD submission format. Several documents were not rendering correctly, leading to formatting issues and potential errors. To address this problem, I collaborated with the technical team to identify the root cause and explored alternative solutions. By utilizing my knowledge of different publishing tools and working closely with the team, we were able to troubleshoot the formatting issues and successfully render the documents correctly. This experience taught me the importance of proactive problem-solving and leveraging cross-functional expertise to find effective solutions.
Note: The answers provided above are for reference and should be personalized based on the individual’s actual experience and expertise.
All the best!
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