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Specialist/ Senior Associate/ Associate Regulatory Requirements
A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
Specialist Regulatory Requirements enable the centralized and harmonized way of working by building and maintaining high-quality in-company regulatory requirement data base and execute focused intelligence searches. Support the continuous improvement by applying learnings and executing continuous regulatory requirements data base updates.
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 Regulatory requirements 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
- 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
- Attention to detail. Ability to spot inconsistencies in the data and to proactively communicate them
- Ability to work with large data bases: to navigate quickly through the available information and to extract the one relevant to the specific search topic
- Project management and documentation skills, proactive communication approach
- Advanced skills with all standard MS office and business applications (word, excel, power point, MS project, outlook, skype, SharePoint)
- Excellent written and spoken English language
- Electronic City Phase 1 - Bangalore
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