Regulatory Affairs Officer, GET STAFFED ONLINE RECRUITMENT LIMITED

About the role

The role will be based at their Innovation Centre in Bedford, UK with option for hybrid working. This is an excellent opportunity for someone looking to take their first steps into working within a Regulatory Affairs department.

Responsibilities

• Prepare and maintain regulatory documentation to support internal and external regulatory requirements.
• Support the development and implementation of quality systems and processes.
• Manage the review and approval of documents related to regulatory affairs.
• Engage with stakeholders to ensure compliance with regulatory standards.
• Handle sensitive and confidential information with integrity and confidentiality.
• Ensure adherence to Quality System, GMP, and ISO compliance.

Requirements

• Highly literate and numerate with a keen eye for detail.
• Passion for accuracy in written work.
• Ability to engage effectively with a range of stakeholders, both within and outside the organisation.
• Good interpersonal skills and excellent written and oral communication skills.
• Previous experience in handling sensitive and confidential information.
• Understanding of Quality System, GMP, and ISO compliance.
• High level of IT literacy.
• Ability to use standard and bespoke software applications.

Qualifications

• Bachelor's degree in a relevant field such as Biotechnology, Chemistry, Pharmaceutical Sciences, or a related discipline.
• Experience in regulatory affairs or a related field.
• Knowledge of Good Manufacturing Practices (GMP).
• Experience with regulatory submissions and compliance.

Skills

• Strong organizational and time management skills.
• Excellent attention to detail.
• Proficiency in Microsoft Office Suite.
• Ability to work independently and as part of a team.

Benefits

• Hybrid working.
• Annual discretionary bonus.
• 25 days paid annual leave plus bank holidays.
• Company pension scheme including competitive employer’s contribution.
• Private Medical Insurance package with additional medical cash plan scheme.
• Enhanced maternity and paternity pay.
• Company supported employee Health and Wellbeing programme.
• Life assurance.
• Free electrical car charging points.
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail).

Pay

Salary: £25,000 – £29,000 DOE plus benefits

Schedule

Full-Time, Permanent