At a Glance
- Tasks: Support regulatory activities and ensure compliance in a fast-paced pharmaceutical environment.
- Company: Join a global healthcare leader in the development of innovative medicines.
- Benefits: Competitive salary, holidays, sick pay, pension, and development opportunities.
- Other info: Hybrid role with excellent career growth and a collaborative team atmosphere.
- Why this job: Kickstart your career in regulatory affairs and make a real difference to patients' lives.
- Qualifications: Recent Life Sciences graduate with strong teamwork and time management skills.
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: Bracknell, UK
Salary: £30,000 per annum; holidays, sick pay, pension
An excellent opportunity for a talented graduate to start a career in regulatory affairs with a global healthcare organisation, our client is a market leader specialising in the development of generic and biosimilar medicines.
Job Purpose
This role supports pre- and post-approval regulatory activities to ensure compliance while meeting business needs. Responsibilities include regulatory submissions, labelling and SmPC updates, stakeholder communication, audit support, archive maintenance, and monitoring departmental projects in line with KPIs, while adhering to global and local SOPs and working instructions.
Your responsibilities will include, but are not limited to:
- Preparation and submission of Marketing Authorisation variation and renewal applications
- Labelling update applications under Article 61(3)
- Change of ownership applications
- Licence cancellations
- Creation, assessment and approval of labelling artwork texts and mock-ups
- Reviewing and updating Summaries of Product Characteristics
- The processing and clear communication of regulatory approvals to internal and external stakeholders
- Monitoring and supporting departmental projects in line with KPIs
- Working in accordance with Global and local Working Instructions and SOPs
- Maintenance of regulatory archives
- Provision of regulatory support for internal and external audits
- Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department
Skills & Experience:
To be considered for the Regulatory Affairs Graduate, you'll need the following skills and experience:
- Recently graduated from a UK university within the last 2 years, with a BSc in Life Sciences
- Ability to be flexible and multi-task within a fast-paced environment
- Experience in Regulatory Affairs within a Generic or Pharma business (desirable)
- Has an understanding of regulatory maintenance processes
- Can effectively cope with change in a fast-moving business
- 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
- IT proficiency and highly proficient in Microsoft Office suite (Outlook, Excel, PowerPoint, and Word)
- Fluency in English - Verbal and Written
The successful candidate will benefit from:
- Team oriented atmosphere
- Cutting edge science
- 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 Bracknell, 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.
Regulatory Affairs Associate (Graduate) in Bracknell employer: Carbon 60
At Carbon 60, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to thrive. Located in Harlow, this hybrid role offers flexibility and the chance to engage with a dedicated Quality team, ensuring your contributions directly impact our commitment to quality excellence. With opportunities for professional growth and development, joining us means being part of a forward-thinking company that values your expertise and dedication.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Associate (Graduate) in Bracknell
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Carbon 60.
We think you need these skills to ace Regulatory Affairs Associate (Graduate) in Bracknell
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Carbon 60.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Carbon 60. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Carbon 60
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Carbon 60.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Carbon 60 achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
