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What is Regulatory Affairs?

What is Regulatory Affairs?

The regulatory function across healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance, are all considered regulatory professionals.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products including:

·       Pharmaceuticals

·       Medical devices

·       In vitro diagnostics

·       Biologics and biotechnology

·       Nutritional products

·       Cosmetics

·       Veterinary products

The Regulatory Affairs professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labelling and advertising and post-market surveillance.

What does a career within Regulatory Affairs look like?

Regulatory Affairs professionals come from a diverse range of backgrounds. Most have earned a Bachelor’s degree, and more than half have an advanced degree – most often in a scientific or technical field. In addition, Regulatory professionals usually have experience in other careers before transitioning into Regulatory Affairs.

Although there are some university degrees and graduate certificate programs in Regulatory Affairs and related areas, experience is a key asset for Regulatory professionals. Valuable skills include project management and organisation, negotiation and communication, and the ability to learn from the experience of others, both inside and outside the organisation.

Continuing with education and professional development is critical to a Regulatory professional. They must keep up-to-date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of healthcare products.

Starting in an entry level position, Regulatory Affairs professionals will typically be working in an administrative function, which will include data entry and the development of simple documents. As they progress their career, knowledge and expertise, their roles will grow to encompass liaising with regulatory authorities and clients on reviews and approvals, while working on the planning for new drug development.

What are the typical roles within Regulatory Affairs?

Pharmaceutical companies, Medical Device companies and Regulatory Consultancies all hire people within Regulatory Affairs. These roles include:

·       Regulatory Affairs Associate/Executive

·       Regulatory Affairs Senior Associate

·       Regulatory Affairs Manager / Senior Manager

·       Regulatory Affairs Director

·       Regulatory Affairs Consultant

·       Regulatory Writer / Medical Writer

How Carrot Recruitment can help you find your next job within the Regulatory sector:

Our specialist recruitment consultant, Hayley Shayestehroo, will be happy to help with all your Regulatory needs within pharmaceuticals, healthcare and devices. She can be contacted on:

+44 (0)1625 361 072 / [email protected]

You can also view all our live Regulatory jobs here or take a look below.

Looking to progress your career within Regulatory Affairs but unsure what your next steps may look like? Check out our useful article on how to progress your Regulatory Affairs career here.

Risk Evidence Senior Associate (Systematic Literature Review)

£ Excellent basic salary, 10% bonus + accelerators, 10% pension, healthcare, WFH for part of the week

Regulatory Affairs Associate

£ Excellent basic salary, bonus, healthcare, 10% pension, some remote working
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