At a Glance
- Tasks: Lead regulatory submissions and manage dossier development for global health authorities.
- Company: Join a globally recognised pharmaceutical leader in a dynamic environment.
- Benefits: Competitive pay, holiday, pension, and hybrid work options.
- Other info: Collaborative and fast-paced environment with opportunities for process improvements.
- Why this job: Gain international exposure and develop expertise in regulatory operations.
- Qualifications: Experience in regulatory submissions and a degree in Life Sciences or Pharmacy.
The predicted salary is between 25 - 26 £ per hour.
Atrium (EMEA) are supporting a global biopharma company looking for a detail-driven Regulatory Affairs Specialist to join a leading pharmaceutical organisation. This is an exciting opportunity to work within Global Regulatory & International Operations, supporting the delivery of regulatory submissions across multiple regions. You will play a key role in managing dossier development and submissions to global Health Authorities, working in a fast-paced, highly regulated environment with cross-functional international teams.
Key Responsibilities
- Lead and coordinate regulatory submission activities for assigned products and markets
- Manage end-to-end submission processes, including planning, document collection, technical build and delivery
- Deliver high-quality electronic and paper submissions in line with global regulatory requirements
- Liaise with global project teams, country affiliates and stakeholders to ensure alignment on timelines and submission requirements
- Oversee translation activities, dossier compilation and submission logistics
- Ensure compliance with regulatory guidelines, timelines and quality standards
- Support process improvements and efficiencies across submission workflows
- Act as a subject matter expert, mentoring colleagues and sharing best practices
- Identify and escalate risks/issues impacting submission timelines
Key Requirements
- Experience in regulatory submissions within the pharmaceutical industry
- Degree or equivalent experience in Life Sciences, Pharmacy
- Experience within pharmaceutical or regulatory environments preferred
- Strong understanding of Regulatory submission processes and Dossier structure and lifecycle management
- Proven ability to coordinate activities in a regulated environment
- Experience with electronic submission systems and tools
- Excellent project management and organisational skills
- Knowledge of the drug development process
Why apply:
- Work with a globally recognised pharmaceutical leader
- Exposure to international regulatory submissions and markets
- Opportunity to develop SME-level expertise in regulatory operations
- Collaborative, fast-paced and impact-driven environment
Regulatory Affairs Specialist in England employer: Atrium
Join a globally recognised pharmaceutical leader as a Regulatory Affairs Specialist, where you will thrive in a collaborative and fast-paced environment. With competitive pay, hybrid working options, and opportunities for professional growth, this role offers the chance to develop your expertise in regulatory operations while making a meaningful impact on global health. Enjoy a supportive work culture that values innovation and efficiency, ensuring you are well-equipped to excel in your career.
