Regulatory Affairs Specialist- Early Development
Posted 2 hours ago
Worldwide
⭐
2-5 years experience
Please mention DailyRemote when applying
AI Summary
Manage and execute regulatory activities for client projects, focusing on clinical trial and early development submissions. Collaborate with Health Authorities and internal experts to ensure high-quality regulatory strategies and compliant dossier delivery.
This is a remote position.
Regulatory Affairs Associate
Advancing patient safety. Building trusted partnerships. Growing careers.
At Arriello, we help pharmaceutical and life sciences organisations navigate complex regulatory requirements while keeping patient safety at the centre of everything we do.
Through our expertise in Pharmacovigilance, Quality & Compliance, and Regulatory Affairs, we support clients across the globe in delivering safe and effective medicines to patients. As our business continues to grow, we are looking for talented professionals who are passionate about quality, collaboration, and making a meaningful impact.
We are proud of our supportive and inclusive culture, where people are encouraged to share ideas, develop their expertise, and contribute to continuous improvement. If you are looking for an opportunity to apply your skills in a dynamic international environment while continuing to build your career, we would love to hear from you.
Our Values
Our values shape how we work every day:
Inclusive – We value fairness, respect, and learning from one another.
Dedicated – We deliver practical, client-focused solutions.
Innovative – We work together to find better ways forward.
Passionate – We build strong relationships and care about the quality of what we do.
The Opportunity
Are you an experienced Regulatory Affairs professional looking for an opportunity to work on innovative medicines and complex early development programmes?
At Arriello, you will play a key role in helping pharmaceutical and biotechnology companies navigate regulatory pathways that support the development of new therapies for patients around the world. This is an opportunity to apply your regulatory expertise in a collaborative, international environment where your contribution is valued and your professional growth is actively supported.
Working as part of our Regulatory Affairs team, you will manage and deliver regulatory activities across a variety of client projects, with a particular focus on clinical trial and early development submissions. You will collaborate closely with clients, Health Authorities, and internal subject matter experts to ensure regulatory strategies and submissions are delivered to the highest quality standards and within required timelines.
If you enjoy solving complex regulatory challenges, building strong client relationships, and contributing to projects that make a meaningful difference to patients, we would love to hear from you.
Key Responsibilities
Regulatory Submissions & Project Delivery
- Manage and execute regulatory activities across assigned client projects.
- Prepare, compile, publish, and submit regulatory dossiers using CTIS, eCTD, IRAS, and other applicable submission formats.
- Support and lead Clinical Trial Applications and early development regulatory pathways, including Scientific Advice, PRIME, Orphan Drug Designation (ODD), Early Access Programmes (EAP), and related submissions.
- Support regulatory strategies throughout early development and pre-approval stages.
- Ensure submissions are delivered accurately, compliantly, and within agreed timelines.
- Ensure compliance with local, regional, and international regulatory requirements.
Regulatory Operations & Compliance
- Coordinate translations, site documentation, and labelling requirements as part of submission activities.
- Maintain accurate regulatory documentation and ensure effective archiving of records.
- Monitor changes to regulatory legislation, guidance, and industry requirements and assess potential impacts on projects and processes.
- Support audits, inspections, compliance activities, and regulatory risk assessments.
- Contribute to the continuous improvement of regulatory systems, procedures, and ways of working.
Stakeholder & Client Management
- Build strong relationships with clients, Health Authorities, vendors, and internal stakeholders.
- Collaborate with cross-functional teams to support successful project delivery and client outcomes.
- Demonstrate a proactive, solutions-focused approach when managing regulatory challenges and client requirements.
Team & Business Contribution
- Support achievement of departmental objectives and key performance indicators.
- Share knowledge, contribute ideas, and support a culture of continuous learning and improvement.
Requirements
Esstential Skills
- Experience supporting CTIS submissions, clinical trial applications, and early development programmes.
- Knowledge of EU regulatory requirements; non-EU experience is advantageous.
- Familiarity with Health Authority interactions and pathways such as Scientific Advice, PRIME, ODD, or EAP.
- Strong project management, organisational, and communication skills.
- Bachelor's degree in a science-related discipline (Biology, Chemistry, Biotechnology, Pharmacy) or equivalent Regulatory Affairs experience.
- 1–3 years' experience in Regulatory Affairs.
- Excellent attention to detail and a pragmatic, solutions-focused approach.
- Fluent English.
- Ability to work effectively in a multicultural, international environment.
Preferred Experience
- Experience supporting post-approval regulatory activities and lifecycle management.
- Experience managing broader regulatory responsibilities across the full product lifecycle.
- Experience working across multiple international markets and regulatory environments.
Benefits
- Flexible working arrangements.
- Opportunities for professional development and career progression.
- Exposure to international clients and diverse project portfolios.
- A collaborative and supportive culture built on knowledge-sharing and teamwork.
- The opportunity to work alongside leading pharmacovigilance and regulatory experts.
- Meaningful work that directly contributes to patient safety and public health.
- Recognition for your expertise, contributions, and achievements.
Equal Opportunities
Arriello is committed to creating a diverse, inclusive, and respectful workplace where everyone is valued and treated with dignity. We welcome applications from all backgrounds and are dedicated to providing reasonable accommodations throughout the recruitment process where required.
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