Job title: SCGM-0, RA Specialist
Company: Merck Ltd
Job description: A career at our company is an ongoing journey of discovery: our 57,000 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.
The Specialist 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 licence 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 support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel
Who You Are:
Experience: Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 1 year of Regulatory affairs experience
Education: Degree in a Life Science or a related discipline, preferably MSc
Job Specific Competencies & Skills
- 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)
- Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally
- Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO s, AFs, CLs, PoA s etc.) as well as legalization framework
- Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
- Adherence to agreed timelines and proactive communication of any potential risk to the same
- Project management and documentation skills, proactive communication approach
- Contributor level of experience with RIM and EDMS RA applications
- Excellent written and spoken English language
- 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, 30 Mar 2021 07:21:33 GMT
Apply for the job now!