Regulatory Affairs Specialist
REF: J5639306
Experience Dependent
Hertfordshire
Contract
Compared to other areas of the pharmaceutical sector, regulatory affairs is a relatively new profession. It has come from the need for companies to ensure the safety and effectiveness of their products for patients and consumers worldwide. Regulatory affairs is applicable to pharmaceuticals, medical devices, biologics and functional foods.
Regulatory affairs is a niche field for which Hyper Recruitment Solutions (HRS) is a specialist recruiter. We list a variety of regulatory affairs jobs through our website, and we spend a lot of time networking with regulatory affairs professionals all over the world to ensure that we are up to date with the latest changes in regulatory legislation. Many of the regulatory affairs personnel we speak to are members of The Organisation for Professionals in Regulatory Affairs (TOPRA).
Regulatory affairs is a niche field for which Hyper Recruitment Solutions (HRS) is a specialist recruiter. We list a variety of regulatory affairs jobs through our website, and we spend a lot of time networking with regulatory affairs professionals all over the world to ensure that we are up to date with the latest changes in regulatory legislation. Many of the regulatory affairs personnel we speak to are members of The Organisation for Professionals in Regulatory Affairs (TOPRA).
Regulatory affairs professionals can be found across the following specialist areas:
- UK Regulatory Affairs
- EU Regulatory Affairs
- International/Global Regulatory Affairs
- Emerging Markets Regulatory Affairs
- Regulatory Operations
- Regulatory CMC
- Regulatory Artwork/Labelling
Here are some examples of regulatory affairs roles at different levels:
- Regulatory Affairs Assistant
- Regulatory Affairs Officer / Executive / Associate
- Regulatory Affairs Senior Officer / Senior Executive / Senior Associate
- Regulatory Affairs Specialist
- Regulatory Affairs Project Manager
- Regulatory Affairs Manager / Senior Manager
- Regulatory Affairs Associate Director/Director
- Regulatory Affairs Vice-President
Take the next step in your regulatory affairs career!
What is Regulatory Affairs?
Regulatory affairs combine a unique mix of scientific, legal and corporate awareness to make sure that products are developed and manufactured in line with industry and government standards. Regulatory affairs professionals work hard to do this by ensuring the necessary licensing, marketing and legal components are all compliant before the product is allowed to enter the marketplace.
A company’s regulatory affairs department can be involved in all steps of the drug development lifecycle, from the early non-clinical studies through to development, as well as the manufacture and marketing stages.
Regulatory affairs professionals form a vital bridge between their company and the regulatory agencies. These agencies include:
A company’s regulatory affairs department can be involved in all steps of the drug development lifecycle, from the early non-clinical studies through to development, as well as the manufacture and marketing stages.
Regulatory affairs professionals form a vital bridge between their company and the regulatory agencies. These agencies include:
Qualified Persons (QP) Jobs FAQs
What is meant by ‘regulatory affairs’?
Regulatory affairs (sometimes abbreviated to RA) refers to a field of expertise that can be found in regulated industries such as medical devices and pharma. It covers everything an organisation might do to ensure that they are complying with all relevant legislation and industry regulations.
Much of RA is concerned with the so-called ‘regulatory climate’ around specific issues – for instance, a regulatory affairs professional working for a pharmaceutical company might have to assess the ‘regulatory climate’ surrounding the promotion of over-the-counter medication.
Much of RA is concerned with the so-called ‘regulatory climate’ around specific issues – for instance, a regulatory affairs professional working for a pharmaceutical company might have to assess the ‘regulatory climate’ surrounding the promotion of over-the-counter medication.
What does a regulatory affairs officer do?
Essentially, the job of a regulatory affairs officer is to ensure that their organisation is fully compliant with all applicable laws and regulations. The role may involve a lot of meetings and travelling around, since an RA officer will frequently act as an intermediary between their employer and the relevant regulatory authorities.
Why work in regulatory affairs?
A career in regulatory affairs can be highly rewarding. Benefits include:
- Salaries ranging from £20,000 (entry level) to £100,000 for the most senior positions
- Plenty of opportunities for growth and career advancement
- Option to work as a consultant once experienced
- An ideal profession for people who like to travel
What is the role of a regulatory affairs professional?
Regulatory affairs professionals are tasked with ensuring pharmaceutical products are effective and safe to use. For example, new medicines will need to be approved by the relevant regulatory body and adhere to strict guidelines at every step of production.
The day-to-day duties of a regulatory affairs officer include.
The day-to-day duties of a regulatory affairs officer include.
- Presenting arguments to obtain licence variations
- Carrying out audits on various pharmaceutical organisations and products
- Analysing product data
- Negotiating with regulatory authorities
- Staying up to date with legislation and best practices
