Regulatory Affairs Specialist

Interested in a career that matters?

The Regulatory Affairs team is a diverse group of regionally focused regulatory specialists covering India, Middle East, Africa, and adjacent markets, working on ingredients, enzymes, and biosolutions.

We work in a highly collaborative and pragmatic way, with close day‑to‑day interaction, knowledge sharing, and joint problem‑solving across markets and with internal stakeholders such as R&D, Commercial, Legal, and Quality. The team values ownership, learning, and proactive engagement.

By ensuring regulatory compliance while enabling innovation and customer solutions, the team directly supports Novonesis’ purpose of driving sustainable biosolutions that benefit people, business, and the planet.

The Regulatory Affairs Specialist will be responsible for managing regulatory activities related to the registration and compliance of our production linked registrations in India and selected MEIA markets. This role requires a good understanding of India regulatory frameworks, strong analytical skills, and the ability to navigate complex regulatory environments and solid stakeholder management.

Key Tasks And Responsibilities

• Support regulatory registrations and lifecycle management for production‑related activities in India and selected MEIA markets
• Collate, compile, and validate regulatory data required for dossiers, including technical, safety, manufacturing, and quality documentation.
• Prepare, review, and maintain regulatory dossiers and submissions under the guidance of senior Regulatory Affairs experts.
• Coordinate closely with internal stakeholders (Regulatory subject matter experts, Manufacturing, Quality, R&D, Supply Chain) to ensure accurate and timely data flow for regulatory purposes.
• Support responses to regulatory authority queries related to registrations, licenses, and production approvals.
• Track submission timelines, commitments, and regulatory status using internal systems and tools.
• Build hands‑on regulatory expertise through active participation in real dossier preparation and interactions with experienced RA professionals.
  
  

The key focus of this role is to manage regulatory registration activities related to production and manufacturing operations in India, including preparation, coordination, and submission of dossiers to relevant authorities, ensuring compliance with applicable food laws, licensing, and approval requirements.

Drive end‑to‑end data collation and dossier readiness by working closely with Manufacturing, Quality, R&D, and Supply Chain teams, translating production and technical information into high‑quality regulatory documentation under the guidance of senior RA experts.

Own tracking and lifecycle management of manufacturing‑related registrations, proactively supporting authority queries, audits, and variations while building hands‑on expertise through active involvement in real dossier development and regulatory engagement

Professional Qualifications

• Minimum of 6+ years of experience in Regulatory Affairs
• Master’s degree in Life Sciences, Chemistry, Biotechnology, or a related field. Advanced degree preferred.
• Demonstrated knowledge of regulatory requirements in India
  
  

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 analytical and problem-solving skills, with attention to detail.
• Proficiency in Microsoft Office suite and regulatory information management systems.
  
  

Hybrid in Bangalore

Our purpose guides 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 weve gotten so far. And it’s how well impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless. If our purpose resonates with you, we encourage you to apply.

Opportunities for everyone

We are committed to an inclusive recruitment process and equal opportunity for all applicants. Therefore we ask you to apply without a cover letter or photo and instead include a few sentences in your CV explaining your motivation for applying.

We make all employment decisions based on business needs and welcome candidates with a wide range of backgrounds, including ethnicity, religion, gender, sexual orientation, age, disability, or veteran status.

Explore Other Openings

If this position isn’t the right fit, you may still find other opportunities with us. You’re welcome to explore open roles or create a job agent to stay connected with future opportunities at novonesis.com/Career

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