Regulatory Affairs Associate; Graduate

Job Title:

Regulatory Affairs Graduate

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

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.

• 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
• 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

• 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)
• Understanding of regulatory maintenance processes
• Can effectively cope with change in a fast-moving business
  
  Ability to demonstrate transferable skills such as good time management, teamwork, through previous work experience, academic achievements or extracurricular activities
• Strong prioritisation skills, able to manage multiple priorities and demonstrate attention to detail under tight deadlines
• Collaborative mindset, ability to develop effective relationships with team members and customers, gaining trust and credibility quickly; comfortable working with people of all levels and backgrounds as part of a cross-functional team
• IT proficiency and highly proficient in Microsoft Office suite (Outlook, Excel, PowerPoint, Word)
• Fluency in English – verbal and written

• Team oriented atmosphere
• Cutting edge science
• Working with diverse people and teams
• Development opportunities
• Making a difference to patient's lives

Willing and able to live within commutable distance of the company site before applying. Placement is based in Bracknell, UK offices, requiring minimum 12 days per month in office to aid your development in working with and learning from your team. Must be eligible to work in the United Kingdom.