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 the following:
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.
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy
Salary description
£29000.00 - £30000.00 per year