Novartis Executive Job Opening For Life Sciences Candidates – Apply Online

Novartis Executive Job Opening For Life Sciences Candidates – Apply Online

Novartis Executive Job Opening For Life Sciences Candidates – Apply Online. Executive Role in Sandoz Global Development. As a key player in the Research & Development division, you will be at the forefront of shaping the future of healthcare. Interested and eligible applicants can check out all of the details on the same below

Role: Executive

Job ID: 362456BR

Division: SANDOZ

Business Unit: Sandoz Global Development

Work Location: Mumbai, India

Company/Legal: EntitySdz Pvt Ind

Functional Area: Research & Development

Job Type: Full Time

Job Description:

1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

Your Responsibilities 

Your responsibilities include but not are limited to:

• Manages medium to small level global regulatory submission projects. Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Managing projects end to end to define regulatory strategy for the regulatory submissions where required. Identify content, quality and/or timelines issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
• Identify the required documentation for regulatory submissions and negotiate the delivery of approved source documents in accordance with project timelines.
• Author high-quality CMC documentation (dossiers) as per Regulatory guidelines, applying CMC regulatory strategies (wherever needed), assuring technical consistency and regulatory compliance, meeting defined timelines and e-CTD requirements.
• Developing professional expertise, applies company policies & procedures to resolve a variety of issues. Frequent internal company and external contacts. Represents organization on specific projects. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Refers to established policies & procedures for guidance.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with stakeholders, partners, and customers.

Minimum requirements:

What You’ll Bring to the Role:

• University or College Degree in any field or life science with relevant industry experience or comparable degree Good communication in English (oral and written).
• At a minimum 4 years experience in the Pharmaceutical area, specifically in Regulatory CMC
• Experience in the Regulatory CMC, area is preferred, Module 3 submissions
• Organizational awareness and experience working cross-functionally and in global teams is a plus
• Ability to work under pressure, demonstrating initiative and flexibility
• High level understanding of Regulatory quality, standards and policies.
• Attention to detail and quality focused

APPLY ONLINE

Interview Questions for the Executive Role in Sandoz Global Development:

1. Can you tell us about your experience in managing global regulatory submission projects? How do you ensure successful project outcomes while maintaining compliance with regulatory requirements? Answer: In my previous roles, I have managed medium to small level global regulatory submission projects. To ensure successful outcomes, I define clear regulatory strategies and identify potential issues with source documents early in the process. I collaborate closely with cross-functional teams to negotiate the delivery of approved source documents within project timelines. Additionally, I author high-quality CMC documentation, adhering to regulatory guidelines and meeting e-CTD requirements, while also ensuring technical consistency and compliance.

2. How do you stay updated with the latest regulatory guidelines and requirements in different global regions? Answer: As a proactive professional, I constantly monitor regulatory updates and subscribe to reputable regulatory news sources. I also participate in relevant webinars, workshops, and industry conferences to stay informed about changing regulations in different global regions. Additionally, I maintain connections with regulatory experts and colleagues in the industry, fostering a knowledge-sharing network.

3. Can you describe your experience in working in cross-functional teams and collaborating with stakeholders, partners, and customers? Answer: Throughout my career, I have worked extensively in cross-functional teams, collaborating with diverse stakeholders, partners, and customers. I understand the importance of effective communication and have successfully maintained sound working relationships with various individuals and organizations. My strong interpersonal skills and ability to adapt to different working styles enable smooth collaboration and promote successful project outcomes.

4. How do you handle pressure and demonstrate initiative in resolving challenges in your work? Answer: Pressure is inevitable in a dynamic work environment, and I believe in staying composed and focused. When faced with challenges, I take a methodical approach, analyzing the situation, and seeking guidance from established policies and procedures when needed. Simultaneously, I demonstrate initiative by proposing innovative solutions, leveraging my expertise and industry insights to find the best course of action.

5. Can you give an example of a project where you had to manage Module 3 submissions? How did you ensure compliance with regulatory quality, standards, and policies? Answer: In a recent project, I was responsible for managing Module 3 submissions for a global regulatory filing. To ensure compliance with regulatory quality, standards, and policies, I closely followed relevant guidelines and conducted thorough reviews of the documentation. I collaborated with subject matter experts to address any gaps or discrepancies and conducted internal audits to maintain a high level of quality and accuracy. Additionally, I ensured that the submission met all regulatory requirements to facilitate a smooth approval process.

6. How do you approach identifying critical issues and lessons learned as a member of the global Reg CMC team? Answer: As a member of the global Reg CMC team, I actively engage in discussions and contribute my insights and expertise. I closely analyze project data and performance to identify critical issues that may impact regulatory submissions. To facilitate continuous improvement, I encourage open communication among team members and promote knowledge-sharing sessions to discuss lessons learned from previous projects. By fostering a collaborative environment, we can collectively enhance our regulatory strategies and ensure successful outcomes for future endeavours.

Remember, when answering interview questions, it’s essential to provide specific examples and showcase how your skills and experiences align with the job requirements outlined in the job description. Be confident, concise, and demonstrate your passion for the role and the company.

Good luck with your interview!

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