Officer & Operations Manager
Manage regulatory documentation workflows, coordinate with pharma clients, and ensure FDA 21 CFR Part 11 compliance across platform operations.
ABOUT ARCASCIENCE
Transforming pharmaceutical decision-making through AI
ArcaScience develops an AI-powered benefit-risk assessment platform that helps pharmaceutical companies make faster, data-driven decisions throughout the drug lifecycle. From clinical development to post-market surveillance, our technology processes millions of data points to deliver actionable insights for regulatory teams, market access specialists, and safety officers.
Our impact:
- Trusted by leading pharma companies including Pfizer, GSK, and Sanofi
- 40% reduction in regulatory documentation preparation time
- FDA 21 CFR Part 11 compliant by design
- Supporting drug development across dermatology, immuno-inflammation, and rare diseases
Our values
- Scientific rigor : We build trust through data accuracy and regulatory compliance
- Collaborative excellence : We succeed together, across disciplines and time zones
- Pragmatic innovation : We balance cutting-edge AI with pharma industry realities
- Continuous learning : We stay ahead of regulatory changes and technological advances
THE ROLE
Officer & Operations Manager
As Officer & Operations Manager, you'll be the operational backbone connecting our AI platform with pharmaceutical client needs. You'll orchestrate regulatory workflows, ensure compliance excellence, and act as the bridge between our technical team and pharma stakeholders.This role is perfect for someone who thrives at the intersection of regulatory affairs, project management, and client operations in the life sciences sector.
YOUR MISSIONS
What you'll work on
Regulatory Operations (40%)
- Manage end-to-end regulatory documentation workflows for multiple pharma clients
- Coordinate submission timelines with FDA, EMA, and other health authorities
- Ensure platform outputs meet 21 CFR Part 11 and GxP compliance standards
- Maintain audit trails and validation documentation
Client Coordination (30%)
- Act as operational point of contact for pharmaceutical clients
- Facilitate onboarding of new clinical projects onto the platform
- Coordinate with Regulatory Affairs, Market Access, and Pharmacovigilance teams
- Track and report on project milestones and deliverables
Process Optimization (20%)
- Identify bottlenecks in regulatory documentation processes
- Develop SOPs for platform usage and data handling
- Implement quality control checkpoints across workflows
- Collaborate with Product team to prioritize feature development
Compliance & Quality (10%)
- Conduct internal audits of platform operations
- Prepare for client and regulatory inspections
- Maintain compliance with GDPR, FDA, and EMA regulations
- Document deviations and implement corrective actions
YOUR PROFILE
The skills and experience we're looking for
Must-have:
- Education: Master's degree in Life Sciences, Pharmacy, or related field
- Experience: 3-5 years in regulatory affairs, clinical operations, or pharma project management
- Regulatory knowledge: Solid understanding of FDA/EMA submission processes and 21 CFR Part 11
- Languages: Fluent in English (working language) and French
- Tools: Proficiency with regulatory information management systems (RIMS) or document management systems
Nice-to-have:
- Previous experience in a pharma/biotech startup environment
- RAC (Regulatory Affairs Certification) or equivalent
- Familiarity with AI/ML applications in life sciences
- Experience with electronic data capture (EDC) systems
- Knowledge of clinical data standards (CDISC, SDTM)
Your mindset:
- Detail-oriented: You spot inconsistencies before they become issues
- Process-driven: You love creating order from complexity
- Client-focused: You anticipate needs and communicate proactively
- Adaptable: You thrive in a fast-paced startup environment
- Collaborative: You work seamlessly across technical and scientific teams
WHAT WE OFFER
What makes ArcaScience a great place to work
Compensation & Benefits
- Competitive salary: €45K-55K depending on experience
- Employee stock options (BSPCE)
- Mutuelle & Prévoyance (Alan)
- 50% public transport reimbursement
- Swile meal vouchers (€10/day)
Growth & Impact
- Shape regulatory operations at a growing AI-pharma company
- Work directly with leading pharmaceutical companies
- Influence product development based on client feedback
- Career progression as the team scales
Work-Life Balance
- 25 days paid vacation + RTT
- Flexible working hours
- Remote work from EU countries (up to 4 weeks/year)
Work Environment
- Hybrid work: 3 days office / 2 days remote
- Modern office in Paris 11ème (near Nation)
- Team rituals: monthly all-hands, quarterly offsites
- Learning budget for conferences and certifications
RECRUITMENT PROCESS
Our hiring process, step by step
Application review - (1 week)
We review your CV and cover letter
Intro call (30 min)
Practical exercise: regulatory workflow optimization scenario
Case study (take-home)
Get to know each other and discuss your background
On-site interviews (2-3 hours)
- Deep-dive with Romain on regulatory operations
- Technical discussion with Product team
- Team fit conversation
Reference checks & offer (1 week)
Ready to transform pharmaceutical decision-making?
ArcaScience is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Contact us
If you have any questions, require assistance, or need to schedule an appointment, we encourage you to contact us.
