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, and the ability to navigate complex environments.
Main tasks
- Support for Updating Regulatory documentation package on RegOne Veeva System (for the region, or globally as required0
- 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 MEIA region
- Support in renewal of memberships, FSSAI licensing activities
- Maintenance of regulatory IT tools. Support 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 Regulatory team in MEIA and Global.
Qualifications / competences
Professional qualifications
- 1-2 years of experience in corporate, or multinational environment preferred
- Bachelor's degree in Life Sciences, Chemistry, Biotechnology, or a related field.
- Demonstrated knowledge of MS Office, 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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Date for last update
Could our purpose be yours? Then apply today!
At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.
Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability, or veteran status.
Want to learn more?
Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com
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