Job title: Senior Specialist Licence ManagementPrevious value
Company: Merck Ltd
Job description: A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
The Expert Licence Management prepare 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 management strategy and approach.
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 9 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.
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 RIM and EDMS, Veeva Vault RA applications
Experienced in managing and handling of paper & electronic dossiers
Awareness of regulatory affairs contributions to Pharma business.
Required demonstrated experience in the project management & related skills.
Capabilities to work in the digital regulatory environment and collaboration workflows.
Excellent written and spoken communication skills and English language knowledge
Electronic City Phase 1 – Bangalore
We have several openings for License Management roles for various levels and profiles
Expectations and scope of responsibilities provided in this Job posting are for Specialist level
The exact designation to be offered will depend on applicants experience and knowledge confirmed during the screening process
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious Apply and find more information at https://jobs.vibrantm.com
Location: Bangalore, Karnataka
Job date: Tue, 14 Dec 2021 08:27:27 GMT
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