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- Tasks: Help submit and maintain global regulatory approvals for innovative medical products.
- Company: Join AMS, a leader in tissue-healing technology with a global impact.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and development.
- Why this job: Be part of a mission-driven team that values innovation and quality outcomes for patients.
- Qualifications: A science-based degree or relevant experience in the medical device field is required.
- Other info: This role involves collaboration with various teams and meeting critical deadlines.
The predicted salary is between 28800 - 42000 £ per year.
Regulatory Affairs Associate (Remote)
Learn More and Apply
https://www.entrytoregulatory.com/jobs/regulatory-affairs-associate
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.
Regulatory Affairs Associate employer: Advance Regulatory Consulting
Contact Detail:
Advance Regulatory Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks in the APAC, EMEA, and LATAM regions. Understanding the nuances of these markets will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the medical device regulatory field. Attend industry conferences or webinars to connect with others who may provide insights or even referrals for the position at AMS.
✨Tip Number 3
Stay updated on the latest trends and changes in medical device regulations. This knowledge can be a great conversation starter during interviews and shows that you are proactive about your professional development.
✨Tip Number 4
Prepare to discuss how you would handle tight deadlines and manage multiple regulatory submissions. Providing specific examples from your past experiences can illustrate your ability to thrive in a fast-paced environment like AMS.
We think you need these skills to ace Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Associate position. Highlight key responsibilities and required skills, such as experience in regulatory roles and knowledge of international markets.
Tailor Your CV: Customize your CV to reflect relevant experience in the medical device field. Emphasize any previous roles that involved regulatory submissions, compliance, or working with international registrations.
Craft a Strong Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the medical device industry. Mention specific experiences that align with the responsibilities listed in the job description.
Highlight Communication Skills: Since excellent communication skills are crucial for this role, provide examples in your application that demonstrate your ability to effectively communicate with various stakeholders, including regulatory authorities and internal teams.
How to prepare for a job interview at Advance Regulatory Consulting
✨Understand the Regulatory Landscape
Familiarize yourself with the regulatory requirements specific to the medical device industry, especially in the APAC, EMEA, and LATAM regions. Being able to discuss these frameworks will demonstrate your knowledge and readiness for the role.
✨Showcase Your Communication Skills
Prepare to highlight your excellent communication skills. Be ready to provide examples of how you've effectively communicated with regulatory authorities or cross-functional teams in previous roles.
✨Demonstrate Problem-Solving Abilities
Think of instances where you had to influence or challenge others constructively to achieve a goal. Sharing these experiences can showcase your ability to navigate complex situations in a regulatory context.
✨Highlight Your Time Management Skills
Since the role requires meeting critical deadlines, be prepared to discuss how you manage your workload and prioritize tasks effectively. Providing specific examples will help illustrate your capability in this area.
