Global Opportunities to Join the Celegence Team
At Celegence, you have the opportunity to shine and truly make a difference. We have a growing organization where your inputs will be valued. We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds. Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment.
Celegence is an Equal Employment Opportunity Employer
All employment decisions at Celegence are made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Celegence is committed to providing a positive work environment as a part of the core Organizational value and is free from discrimination and harassment, and we will not tolerate any form of unlawful discrimination or harassment.
Why work at Celegence?
Be a part of a remarkable journey!
Collaborative Team
Here at Celegence, you get a great team that always stands by you.
Supportive Manager
A supportive Manager who makes sure you are absolutely comfortable with the work you’re doing.
HR team
An amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then).
Leadership Team
Here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.
- Bangalore
- Onsite, Hybrid
- Reporting to Director, Pharma RA Services
Celegence LLC is a privately owned consulting organization headquartered in Chicago, Illinois (USA), with offices across the UK, Europe and India. The company delivers regulatory affairs consulting services and technology solutions to the global Life Sciences industry.
Our experienced professionals support customers in their day-to-day regulatory operations by ensuring global compliance, applying deep scientific expertise and leveraging technology and automation to improve operational efficiency.
Our vision is to become the premier niche provider of regulatory services and innovative technology solutions, enabling life science organizations to deliver exceptional patient value through end-to-end regulatory excellence.
Qualification
Postgraduate or Graduate in Pharmacy, Life Sciences, or a related technical/scientific discipline (Postgraduate preferred)
- Deep knowledge of ICH M4Q guidelines, specifically Module 3 (3.2.S Drug Substance and 3.2.P Drug Product) requirements.
- Hands-on experience with authoring CMC sections for IND, NDA, MAA and lifecycle management activities.
- Global Health Authority regulatory compliance including US FDA, EMA and MHRA.
- Understanding of AI regulatory landscape across the US FDA and Europe.
- Hands-on experience with CARA, Veeva and D2 eDMS platforms including document creation, workflows and content planning.
- Exceptional verbal, written and technical communication skills.
- Excellent stakeholder management skills across engineering teams, service delivery groups and pharmaceutical clients.
- Strong negotiation and conflict-resolution abilities to manage regional lifecycle timelines.
Translational Thinker
Natural ability to balance a technology product mindset with highly regulated pharmaceutical compliance frameworks.
Meticulous & Quality-Driven
High cognitive discipline with an uncompromising focus on First-Time-Right (FTR) data integrity and quality.
Resilient Under Pressure
Maintains composure, clarity and focus while responding to changing health authority requirements and demanding project timelines.
Proactive Collaborator
Self-motivated, enthusiastic and highly effective at building strong relationships across R&D, Quality and Technology teams.
- Regulatory Subject Matter Expert
- Serve as the primary Regulatory Subject Matter Expert (SME) for the AI software development workstream.
- Drive business requirements, particularly for Module 3 CMC content, ensuring the platform meets pharma readiness and operational delivery standards.
- AI Platform & Document Authoring
- Leverage AI platform capabilities to streamline regulatory document creation.
- Integrate reviewer feedback while maintaining consistency, clarity and compliance throughout document authoring.
- Process & SOP Development
- Define cross-functional business processes and Standard Operating Procedures (SOPs).
- Develop training modules to harmonize regulatory services with technology deployment.
- Project Planning & Reporting
- Manage project timelines and estimate effort for strategic initiatives.
- Prepare projections, utilization reports and progress updates for leadership review.
- Client-Focused Regulatory Solutions
- Deliver highly customized regulatory solutions aligned with client requirements.
- Ensure documentation meets regional expectations for language, content, formatting and presentation.
