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 Work Experience Placement at Entry to Regulatory.
It is an unpaid voluntary internship that will provide you with experience in the following areas:
- EU Variations
- US clinical trial IND authoring
- Marketing Authorisation Application preparation for EU/UK
- Regulatory strategy
- Regulatory intelligence project (if available)
In addition, you will learn about the regulations, regulatory submissions and processes for the EU, UK and US markets across the whole product lifecycle (clinical trials, marketing authorisation applications and variations).
You will work under the supervision of an experienced regulatory professional, who will review your work and provide feedback and a reference upon satisfactory completion of the regulatory affairs internship.
This internship is associated with the Introduction to Regulatory Affairs Course.
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
Optional Requirements
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
Entry level role. No previous regulatory experience needed
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.