Novonesis Regulatory Affairs Associate Job For Chemistry, Apply Online
Junior Regulatory Affairs Associate
Remote type: Hybrid
Locations: Bangalore
Time type: Full time
Posted on: Posted Today
Time left to apply: End Date: January 30, 2025 (30+ days left to apply)
Job requisition ID: JR103969
Are you ready for a new beginning?
We need your talent, knowledge, and dedication to better our world with biology.
Our purpose points the way
In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we’ve gotten so far. And it’s how we’ll impact the future.
Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.
We’re here to better our world with biology.
Position: Junior Regulatory Affairs Associate
Department / Division: Regulatory Affairs and Product Safety department
Reports to: Mansi Kulshreshtha
Direct references: NA
Location: Bangalore, India (Hybrid)
Overall role and responsibility
The Junior Regulatory Affairs Associate will be responsible for driving compliance of Regulatory activities to our in-house tool, RegOne.
The person managing these activities will also help us with:
- Regulatory monitoring
- Renewal of association memberships
- FSSAI licensing activities related to the registration and compliance of our Biotechnology solutions in Middle Eastern, India, and African markets
This role requires:
- A basic understanding of MS Office
- Good stakeholder management
- The ability to navigate complex environments
Main tasks
- Support for updating the Regulatory documentation package on RegOne Veeva System (for the region, or globally as required)
- Support to build RegOne Libraries for customer statements and questionnaires
- Coordinate and respond to customer or stakeholder requests
- Monitor relevant regulatory changes and support in regulatory monitoring for the MEIA region
- Support in renewal of memberships and FSSAI licensing activities
- Maintenance of regulatory IT tools and support for the local RA team as needed
- Candidate will be challenged by working in a global environment and handling complex IT tools to ensure state-of-the-art regulatory compliance
Other tasks
- Support Global Regulatory Affairs initiatives and activities
Expected travels
- None. The role is based out of Bangalore, India, with an interphase to the Regulatory team in MEIA and Global.
Qualifications / Competences
Professional qualifications
- 1-2 years of experience in corporate or multinational environments preferred
- Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, or a related field
- Demonstrated knowledge of MS Office and other tech tools
- Excellent written and verbal communication skills in English
Competences
- Proven ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment
- Strong problem-solving skills with attention to detail
- Proficiency in Microsoft Office suite and regulatory information management systems
Focus areas
- Registrations
- Regulatory affairs
- Regulatory expertise
Misc.
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