About the Role
Part time, remote, home working role
Entry level regulatory affairs role. No previous experience needed.
Multiple positions available globally. Applicant can be based anywhere.
This is a part-time remote role for a Regulatory Affairs Associate at Advance Regulatory Consulting.
The Regulatory Affairs Associate will be responsible for:
- Regulatory intelligence project
and/or under the supervision of a senior colleague:
- Handling EU, UK and US regulatory documentation
- Ensuring compliance with regulatory requirements throughout the product lifecycle (clinical trials, marketing authorisation applications and variations)
- Preparing and submitting regulatory submissions
- Managing overall regulatory affairs activities on a day-to-day basis.
Prospective Job Application for any current or future job openings.
Further information on the projects the candidate will be working on will be provided at interview stage.
Requirements
Entry level role.
Essential Requirements
Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or related field
Strong interest in Regulatory Affairs
Ability to work independently and as a team
Ability to be self motivated (to work remotely)
Familiarity with Microsoft Office
Attention to detail, problem solving, organisational skills
Communication, ability to work under pressure and to tight timelines
Ability to manage multiple projects simultaneously
Understanding and critical review of technical scientific information and regulations
Ability to research information
Optional Requirements
Pharmaceutical industry experience or regulatory affairs experience preferred
Regulatory knowledge (e.g. through a regulatory course) preferred
About the Company
Advance Regulatory Consulting is an innovative regulatory affairs consultancy based in the UK that provides end-to-end regulatory affairs services to the pharmaceutical industry from product development, through to licensing and post-approval maintenance.
Our experts have extensive experience in regulatory affairs and include former Agency Assessors. Our experience covers all types of medicinal products, markets (EU, US, UK and rest of world) and therapeutic areas, involving small molecules, biologicals, vaccines, branded and generic products. We accelerate innovation through our highly-respected regulatory affairs team who possess significant experience in delivering regulatory solutions and strategic guidance to a wide portfolio of clients to tackle some of the most technically challenging projects and deliver successful client outcomes that are flexible, cost-effective and offer exceptional value from both commercial and scientific standpoints.