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.
Our company will be looking for several (Senior) Coordinator and Specialist positions for our newly established Regulatory Excellence Center in Bangalore.
The Regulatory Excellence Center will be a unique platform within the Global Regulatory Affairs, powering our integrated execution.
We seek applicants with a degree in a Life Science or a related discipline, preferably MSc
The entry Coordinator level positions require 1-2 years of industry experience.
For the Senior Coordinator and Specialist roles, the expectation is for 2-6 years of experience.
Both Coordinator and Specialist roles will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. Some of the positions will provide an exposure to a communication with external stakeholders as well (i.e. CMOs, Vendors, Health Authorities).
ACCOUNTABILITY and INDEPENDENCE:
Each role will be set clear expectations to the own accountability, the interdependencies and strict criteria on the quality of the own deliverables.
JOB SPECIFIC COMPETENCIES AND SKILLS
- Experience in preparation and management of regulatory documentation, including new product applications and large variations
- Good knowledge of global pharmaceutical legislation and regulatory affairs
- Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
- Practical experience in one of the following areas for small or for biotech molecules: submission project management, CMC, Labelling and artworks, including authoring of some parts of the dossier, preparation of answers to HA questions, PV, QA
- Hands on experience with various Regulatory IT applications: DMS, RIM systems, Publishing and validation tools, e-portals
- Hands on experience with various MS applications: Word, Excel, Power point, SharePoint, Outlook
- Basic Project management/ Submission project management
- Ability to plan and organize the own workload and tasks, and to cohere to the project plans acknowledge with the team
- Ability to comply with processed and SOPs to full extent
- Excellent written and spoken communication skills in English
- Good interpersonal skills and flexible mindset
- Attention to details
- Ability to work in teams
- Desire to learn and develop
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