Merck Life Sciences Specialist License Management Job – Apply Online

Merck Life Sciences Specialist License Management Job – Apply Online

Merck Life Sciences Specialist License Management Job – Apply Online. MSc, PhD life sciences job openings at Merck – Specialist License Management Job – Apply Online. Interested and eligible applicants can check out all of the details on the same below

Specialist License Management

Job Requisition ID: 266225

Location: Bangalore

Career Level: D – Professional (4-9 years)

Working time model: full-time

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

Role:

The Specialist Licence Management prepares dossiers and execute actions that support the license security and product compliance on the markets, and that meet company’s and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license

Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to work on complex tasks and to propose solutions and strategies as part of their day to day work.

Who You Are:

Experience: Minimum 4 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 3 years of Regulatory affairs experience.

Education:

Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

Job Specific Competencies & Skills:

• Ability to contribute to the dossier content and to perform content and quality review on regulatory documentation
• Ability to develop and prepare successful regulatory strategies and dossiers
• Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations
• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
• Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements
• In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc.) and LCM strategies
• Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
• Strong project management and documentation skills, proactive communication approach
• Ability to execute appropriate risk assessment and mitigation in cooperation with line manager /team lead
• Ability to provide Regulatory expertise into the planning and execution of projects and tasks
• Ability to work within a matrix organisation, build relationships with internal or external stakeholder
• Contributor level experience with Veeva Vault Registration module and EDMS RA applications
• Excellent written and spoken communication skills and English language knowledge

Job Location:

Electronic City Phase 1 – Bangalore

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Here are five possible interview questions that could be asked in the technical round for the “Specialist License Management” job, along with their answers:

1. Question: Can you explain the role of a Specialist License Management and its significance in ensuring license security and product compliance? Answer: The role of a Specialist License Management is crucial in preparing dossiers and executing actions that ensure compliance with licensing regulations and product security. They work collaboratively with various disciplines to develop license management strategies that meet both company and health authorities’ requirements. This role plays a vital part in maintaining regulatory compliance and securing licenses for our products, which are essential for maintaining the integrity of our business operations and ensuring customer safety.
2. Question: How do you approach the preparation of regulatory strategies and dossiers for international submissions? Can you provide an example of a successful strategy you’ve developed? Answer: When preparing regulatory strategies and dossiers for international submissions, I begin by thoroughly analyzing the specific regulatory requirements of each region. I then work closely with cross-functional teams to gather the necessary data and documentation. An example of a successful strategy I’ve developed was for a new product application in Europe. By aligning our submission with the latest regulatory guidelines and leveraging our in-depth knowledge of the regulatory landscape, we achieved a streamlined approval process and a successful market launch.
3. Question: Describe your experience in handling life-cycle management activities in different regions. How do you ensure compliance and consistency across various regulatory procedures? Answer: I have hands-on experience in life-cycle management activities in both the European and US regions. To ensure compliance and consistency across various regulatory procedures, I stay updated on regional regulatory changes and guidelines. I also collaborate closely with global regulatory teams to share best practices and ensure alignment. By maintaining a clear understanding of each region’s requirements and leveraging effective communication, I ensure that our life-cycle management strategies remain compliant and consistent across the board.
4. Question: Can you provide an example of a complex task you’ve worked on in your previous role and how you proposed a solution or strategy to overcome challenges? Answer: In a previous role, I was tasked with managing a large variation submission for a product in multiple regions. The challenge was to ensure that each submission adhered to the specific requirements of each region while maintaining consistency in the overall strategy. To address this, I collaborated closely with the regulatory team and developed a comprehensive submission plan that outlined region-specific variations and a unified core dossier. This approach streamlined the submission process, minimized redundancies, and ensured compliance with regional requirements.
5. Question: How do you approach risk assessment and mitigation in the context of regulatory affairs? Can you share an example of a situation where you effectively managed regulatory risks? Answer: When approaching risk assessment and mitigation in regulatory affairs, I begin by identifying potential risks that could impact regulatory submissions or compliance. I work closely with my team and line manager to assess the severity of each risk and develop mitigation strategies. For instance, in a recent project, we identified a potential discrepancy between regional labeling requirements. To mitigate this risk, we proactively engaged with local regulatory authorities, clarified the requirements, and adjusted our labeling accordingly. This proactive approach ensured smooth submissions and minimized the risk of delays or non-compliance.

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