SRG
Graduate Regulatory Writer
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Job Title: Graduate Regulatory Writer
Job Type: 12 Months Fixed Term Contract
Employment Start Date: ASAP
Hours of work: Mon – Fri (37.5 hours a week)
Onsite requirement: This will be a hybrid role, with at least 3 days per week on site
Industry: Pharmaceuticals
Location: London, UK
Salary: £31,050 per annum; holidays, sick pay, pension
An excellent opportunity for a talented graduate to start a career in regulatory affairs with a global healthcare leader, our client has one of the most exciting product pipelines in the industry today. Our mission is to improve patients' lives by providing customers with innovative science and differentiated healthcare solutions delivered by diverse and engaged talent with integrity, passion and focus on performance. Creativity and diversity are encouraged, impact is recognised, success is celebrated, and people feel valued and listened to.
The Opportunity
The successful candidate will gain hands-on experience supporting the preparation of regulatory documents used throughout the drug development process and for submission to health authorities worldwide. Working within a global cross-functional environment, you will collaborate with colleagues from Regulatory Affairs, Clinical Development, Clinical Operations, Statistics and Drug Safety while developing valuable scientific communication and regulatory writing skills.
Your responsibilities will include, but are not limited to:
- Support the preparation and review of regulatory documents for submission to health authorities.
- Develop high-quality regulatory documents using approved templates, style guides and regulatory writing best practices.
- Collaborate with colleagues across Statistics, Clinical Operations, Clinical Development, Drug Safety and Regulatory Affairs to support the development of regulatory document content.
- Contribute to the planning and presentation of scientific and clinical data within regulatory documents.
- Support regulatory writing project plans and timelines to ensure deliverables are produced on time.
- Participate in cross-functional project teams and contribute towards achieving key project milestones.
- Learn and apply relevant regulatory requirements, company standards and industry best practices.
- Develop proficiency in regulatory writing technologies, document management systems and AI-enabled tools.
- Support continuous improvement initiatives and the sharing of best practices within the Regulatory Writing & Submissions team.
- Maintain compliance with training requirements, SOPs and quality standards.
- Undertake other Regulatory Writing & Submissions activities as required.
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Skills & Experience:
To be considered for the Graduate Regulatory Writer role, you'll need the following skills and experience:
- Recently graduated from a UK university within the last 2 years, with a degree in Life Sciences, Biomedical Sciences, Biological Sciences, Pharmacy, Pharmacology, Chemistry, Medical Sciences, Regulatory Affairs or a related scientific discipline.
- Clear motivation and ambition to gain experience in a regulatory affairs environment.
- Knowledge of the pharmaceutical industry, clinical research, regulatory affairs or drug development.
- Experience within the UK healthcare and/or pharmaceuticals environment is advantageous, although not necessary.
- Ability to demonstrate transferable skills to the business environment, such as good time management and teamwork, through previous work experience, academic achievements, or extracurricular activities.
- Strong prioritisation skills, with the ability to effectively manage multiple priorities and demonstrate attention to detail, even under tight deadlines.
- Collaborative mindset, with the ability to develop effective relationships with team members and customers, gaining trust and credibility quickly. You should be comfortable working with people of all levels and backgrounds as a valuable member of a cross-functional team.
- Customer-focused approach, delivering high-quality projects and activities to both internal and external stakeholders. You should be aware of and responsive to their needs.
- IT proficiency and highly proficient in Microsoft Office suite (Outlook, Excel, PowerPoint, and Word).
- Fluency in English – Verbal and Written
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The successful candidate will benefit from:
- Exposure to a highly specialised area of the pharmaceutical industry
- Development of scientific writing and communication skills
- Insight into drug development, clinical research and regulatory submissions
- Team oriented atmosphere
- Working with diverse people and teams
- Development opportunities
- Making a difference to patient's lives
Additional Information
Please ensure that you are willing and able to live within commutable distance of the company site before applying. This placement is based in their London, UK offices, and you will be required to be in the office a minimum of 12 days per month, to aid your development in working with and learning from your team. You will need to be eligible to work in the United Kingdom.
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