Senior Regulatory Affairs Specialist – UK & IRL, Remote

Scienceabode; Cambridge; Hybrid; GBP 60,000 - GBP 80,000; Full time

Job summary

A global pharmaceutical company is seeking a Pharmaceuticals Regulatory Affairs Associate to support regulatory strategies for drug products. The role involves managing product portfolios and ensuring compliance with UK and Ireland regulations. Ideal candidates should have a relevant degree and experience in regulatory submissions. This position offers a hybrid working model, with the option to work from home or on-site in Newbury for the remainder of the contract, which is initially for 12 months.

Qualifications

• Experience in product labelling activities and regulatory drug submissions.
• Familiarity with Windsor Framework compliance.
• Ability to compile regulatory documents for submissions.

Responsibilities

• Support regulatory strategies for assigned product portfolios.
• Manage local Regulatory Affairs activities.
• Assist in preparation and review of labelling and local SOPs.

Skills

UK and Ireland drugs regulatory labelling requirements

Regulatory Authority submissions

Excellent project management skills

Computer skills (Word, Excel, Power Point, Outlook)

Good project management experience

Education

Bachelor’s degree or equivalent in a relevant scientific discipline

Job description

A global pharmaceutical company is seeking a Pharmaceuticals Regulatory Affairs Associate to support regulatory strategies for drug products. The role involves managing product portfolios and ensuring compliance with UK and Ireland regulations. Ideal candidates should have a relevant degree and experience in regulatory submissions. This position offers a hybrid working model, with the option to work from home or on-site in Newbury for the remainder of the contract, which is initially for 12 months.