Regulatory Analyst
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Job Location:
Yearly Salary:
Experience Required:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Description:
Our prestigious client is seeking an experienced Regulatory Analyst to join a fast-paced innovation-driven biotechnology client. This role focuses on ensuring compliance with international regulatory requirements. For product development clinical trials and commercialization processes in the healthcare or life sciences sector.
The successful candidate will be responsible for compiling reviewing and submitting documentation to regulatory authorities and maintaining up-to-date knowledge of changing industry standards.
Key Responsibilities:
- Prepare submit and track regulatory filings such as INDs NDAs CTAs and amendments.
- Ensure compliance with FDA EMA MHRA and other global regulatory agencies.
- Monitor legislative and regulatory changes affecting product development and advise stakeholders.
- Collaborate with R&D clinical and legal teams to compile documentation for approvals.
- Maintain regulatory documentation databases and assist in audits or inspections.
- Support product labelling reviews and ensure proper documentation for promotional material approvals.
- Provide input on regulatory strategies during product lifecycle stages.
Requirements
Required Skills:
- Strong understanding of EU and FDA regulatory frameworks and submission processes.
- Experience working with regulatory submission platforms (e.g. eCTD).
- Excellent technical writing documentation and communication skills.
- Ability to manage multiple projects with attention to deadlines and compliance.
- High level of attention to detail and analytical thinking.
Desired Skills:
- Experience in biotechnology or pharmaceutical regulatory consulting.
- Familiarity with medical device regulations (MDR IVDR).
- Knowledge of ICH guidelines GxP and ISO standards.
Benefits
Job Benefits:
- Competitive base salary & performance bonus
- Hybrid working flexibility
- 25 days annual leave bank holidays
- Private medical insurance
- Professional development and certification support
- Inclusive growth-oriented company culture
Required Skills:
Required Skills Deep knowledge of digital payment ecosystems architectures and technologies Expertise in payment gateway integration tokenisation and fraud detection systems Strong understanding of ISO 20022 EMV NFC and 3D Secure protocols Familiarity with cloud-native architecture (AWS GCP or Azure) Ability to document and present technical concepts to stakeholders clearly Desired Skills Experience with real-time payment systems and blockchain-based solutions Hands-on coding experience with Java Python or TOGAF or AWS Solution Architect certification preferred Knowledge of financial data orchestration and embedded finance architectures
Company Industry
IT Services and IT Consulting
Key Skills
- Hair And Beauty
- Facilities
- IT Support
- Bank
- Asp.Net MVC
