Regulatory Affairs Specialist [Level 7]

Unlock Your Potential with our Regulatory Affairs Specialist Level 7 (L7) Degree Program

The Regulatory Affairs Specialist Level 7 Program centers on ensuring healthcare products for human and animal use are licensed before sale. Regulatory affairs, crucial in this process, involves obtaining licenses from authorities or demonstrating compliance with laws. The Regulatory Affairs Specialist is pivotal in developing strategies for legal product development and managing marketing authorizations.


  • Create and implement regulatory strategies
  • Conduct research for regulatory solutions
  • Project manage license applications
  • Provide guidance on regulatory matters
  • Prepare and deliver regulatory operational plans
  • Ensure optimal stakeholder interactions
  • Comply with processes, data requirements, and standards
  • Mitigate and manage risks
  • Evaluate data for suitability and identify gaps

Core Knowledge:

Regulatory Affairs Specialists understand the regulatory environment, product lifecycle management, evidence for regulatory decision-making, regulatory procedures, and impact.


  • Manage and deliver multiple projects
  • Act decisively in complex situations
  • Influence and negotiate effectively
  • Think analytically and offer creative solutions
  • Present and communicate complex information
  • Manage and share knowledge
  • Use initiative to contribute to a team
  • Work with IT platforms


Regulatory Affairs Specialists demonstrate integrity, accountability, independence, commitment to personal development, compliance, and customer focus.

Entry Requirements:

Typically, a degree in science, engineering, or law is required. English and Maths proficiency is necessary, with alternatives for those with special language needs.

Professional Registration:

Successful completion allows membership in The Organisation for Professionals in Regulatory Affairs (TOPRA) and eligibility for professional registration as a Registered Scientist (RSci).

Program Details:

  • Level: 7
  • Duration: Typically 30 months
  • Review: After 3 years

The Regulatory Affairs Specialist role is a complex and demanding one, requiring a unique blend of skills, knowledge, and behaviors. Through the lens of these YouTube resources, individuals aspiring to enter this field or those seeking a deeper understanding of its intricacies can glean valuable insights. From the daily challenges to the overarching impact on healthcare, Regulatory Affairs Specialists play an indispensable role in ensuring the safety, efficacy, and compliance of the products that touch the lives of millions.

Additional Resources

1. The Regulatory Affairs Specialist Journey

This video provides an insightful journey into the day-to-day life of a Regulatory Affairs Specialist. It explores the challenges and rewards of navigating the regulatory landscape, emphasizing the importance of attention to detail and a comprehensive understanding of evolving regulations. Aspiring professionals can gain valuable insights into the skills and traits required to thrive in this role.

2. Key Responsibilities of Regulatory Affairs Specialists

This resource focuses on the key responsibilities shoulder by Regulatory Affairs Specialists. From developing and implementing regulatory strategies to managing the intricate web of stakeholders, the video breaks down the critical tasks that define success in this field. It also highlights the diverse sectors within healthcare, such as pharmaceuticals and medical devices, where Regulatory Affairs Specialists make a significant impact.

3. Regulatory Decision-Making and Impact

Delving into the decision-making processes of Regulatory Affairs Specialists, this video sheds light on the scientific foundations that underpin their evaluations. It explores the impact of regulatory decisions on businesses, patients, and the future landscape of healthcare. Understanding the importance of vigilance, risk management, and compliance is central to appreciating the gravity of this role.

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What to know about a Clinical Trials Specialist degree apprenticeship and how to apply now

Interested in a career in Clinical Trials? Look no further as this level 6 degree apprenticeship as a Clinical Trials Specialist could jump start your career in the health and sciences field. Here is everything you need to know about the role and more information on what qualifications you need to apply.

This apprenticeship is designed to equip you with the necessary skills and knowledge to become a Clinical Trials Specialist. You’ll learn how to manage, plan and execute clinical trials and you’ll also gain experience in data management, regulatory affairs, and patient safety. This is great role for anyone looking to get into the health and sciences field.

The typical duration for this apprenticeship is 60 months, however this does not include your EPA period. The role pays up to £26000 and the EQA provider is Ofqual. This is a level 6 non integrated degree level apprenticeship.

The whole duration typically takes 5 years. and results in a qualification of a BSc (Hons) degree including but not limited to biological science in Physiology, Anatomy, Pharmacology, Pharmacy or Biochemistry.

Key Responsibilities

As a Clinical Trials Specialist apprentice, your duties and responsibilities will include:

  • Providing support to managers whilsts planning and managing clinical trials
  • Ensuring compliance with GCP guidelines
  • Produce and file high quality reports and regulatory documents
  • Ensuring patient safety
  • Maintain study tracking systems (incl. eClinical Trial Management Systems (eCTMS), finance and budget management systems, eCase Report Form (eCRF) and trial status reports)

Essential Skills and Qualities

Having the below traits will help you succeed in this apprenticeship:

  • A strong understanding of science and biology
  • Excellent attention to detail
  • Strong problem-solving skills
  • Have a ‘patient first’ attitude and strong communication skills
  • A commitment to ethical principles
  • Be flexible in your approach and adaptable

Educational Requirements

To apply for this apprenticeship, you will need to have:

  • A GCSE in English and mathematics at grade C or above
  • A Level 3 qualification A levels/B-Tech in one science related subject.

What career prospects can you expect after completion?

Clinical Trials Specialists are in high demand across the pharmaceutical, biotechnology, and healthcare sectors. With experience, you could progress to senior positions such as Clinical Project Manager or Clinical Research Manager.

Below is a video about the role of a Clinical Trials Manager which can give you more information on career progression after this apprenticeship. It is worth watching to see one of the many next steps that could be available to you after this learning opportunity

Benefits of starting you clinical trials career as an apprenticeship

Starting your career as an apprentice is a great opportunity! You enter the workplace in a learning position, which allows you to confidently ask questions and request information that can help you quickly progress in your career. You are able to meet with colleagues of all levels and can ask to participate in multiple projects as part of your apprentice learning opportunity. Further benefits include;

  • Gaining hands-on experience
  • Learning from experienced professionals
  • Earning a competitive wage
  • Networking opportunities

How to Apply

If you are interested in applying for this apprenticeship, you can do so here on the Institute for Apprentices website

More information

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Also remember that you can reach out to us directly via the website if you have any more questions, we are more than happy to help! Contact us here

A health care science course that anyone can achieve: an apprenticeship

A health care apprentice taking care of a patient as part of their course

Do you want to progress, but see no route in your own profession? Ever wondered what it would’ve been like if you’d taken a health care qualification like your colleagues? Well you can, with an apprenticeship!

For those of you who aren’t quite sure, this means you can keep earning whilst you learn! No university debt or fees, no extra hours of work on weekends. All this Level 6 apprenticeship (equivalent to an accredited bachelors health care degree) requires of you is your compassion; honesty; and conscientiousness towards others. This health care apprenticeship can earn you an average salary of 34K. Followed by opportunities to further progress your career after your apprenticeship. Completion of the healthcare course also awards you eligibility to apply as a Biomedical Scientist or join the accredited Register of Clinical Technologists for example.

So what does the role entail?

  • You will become an expert in applied science techniques, delivering patient sensitive tests and procedures (in some cases, including specialist therapeutic interventions). You will work on samples, patients and other equipment.
  • You’ll be responsible for the analysis of a wide range of diagnostic tests that contribute to the clinical assessment of patients for the presence of disease, the monitoring of health and the effectiveness of treatments
  • You’re required to use judgement, deal with ambiguity and supervise the training of others in the trainee practitioner and support workforce
A level 6 health care apprentice completing their degree on their laptop

Skills you will learn as a care practitioner:

  • Ensuring the highest standards of person-centred care are practised so that each person is treated with dignity and respect with equality and diversity legislation, policies
  • Identifying ways of promoting good mental health/well being and the use of appropriate language to share complex information with the public, patients and colleagues, including giving and receiving feedback
  • Critically reflecting on your practice, keeping your knowledge and skills updated autonomously as a practitioner by responding to appraisal/feedback
  • Be responsible for the safety and functioning of equipment and use research, reasoning and problem solving skills to support improvements/innovation in health care science

The health care apprenticeship is typically a minimum of 36 months long. As a healthcare practitioner you can work in a range of different settings including hospitals, primary care, public health, and private sector hospitals – so there are many opportunities to find the right environment for you… Maybe it might be somewhere you already work, but in a new position. Or maybe this is completely new for you and that’s awesome! has more information on how to find the right course and training provider for you, but feel free to reach out to us on social media with any care qualification questions:


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Level 4 Associate Ambulance Practitioner

Level 4 Apprenticeship

Check out the high pace Heath and Science Level 4 Apprenticeship

No two days are the same in this high intensity patient centred career. Problem solving with a close nit team of highly trained health care professionals. With a wide range of duties assisting from accident to hospital. Read on to find out if this is a potential career for you.

Jobs and entry criteria for the level 4 Associate Ambulance Practitioner (AAP)

The Associate Ambulance Practitioner apprenticeship gives apprentices a chance to learn the skills required to progress in the wide range of jobs that the NHS/private healthcare has to offer. Including jobs like: Paramedic, Ambulance Technician, Emergency Care Assistant. You’ll be on the front line of the health service, helping people that need it the most. By learning on the job, you can get hands on experience from expertly trained Registered Practitioners.

To start this level 4 apprenticeship, you’ll need to be 18 years+, complete a fitness test, hold a full UK driving licence, be supported by an employer, interview and complete a behaviour test that supports these AAP values:

  • Patient Centred – be professional and passionate
  • Dignity & Respect for all – be understanding and promote equality
  • Teamwork – guide and support others 
  • Care & Compassion – be compassionate and kind 
  • Effective Communication – be open and honest
  • Competence – maximising your learning opportunities 

No previous qualifications are needed but the employer may have their own requirements. After completing the course (normally 12 to 18 months long), you will have achieved: Level 2 functional skills in English & Maths (if not already achieved); Level 2 Award in Ambulance Driving (QCF); Level 3 Certificate in Emergency Response Driving (QCF); Level 4 Diploma in Associate Ambulance Practitioner (QCF).

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Key responsibilities of an Associate Ambulance Practitioner apprentice

The day-to-day duties of an AAP involve working within the ambulance crew responding to emergency calls and providing urgent assistance by driving safely at high speed to a destination. Once arriving the APP will assist their team to reduce the need for hospitalisation hoping to discharge at the scene. If this is not possible the APP will transport the patient to the nearest relevant care provider. Other tasks involve working closely with other emergency services and the wider NHS. The APP will need to use problem solving skills/depth of knowledge to deescalate situations while listening to team member’s ideas and following guidelines.

Level 4 Associate Ambulance Practitioner Core Competencies

As part of your job role, you will learn the following skills:

  • Core Skills – communication, conflict resolution, health & safety, safeguarding, duty of care, confidentiality
  • Moving & Handling – risk assessment and use of correct equipment
  • Assessment & Measurement – follow a stepwise and holistic approach to patient assessment
  • Treatment & Intervention – have practical knowledge of treating a broad range of injuries
  • Intermediate Life Support & assisting the practitioner – use appropriate equipment and techniques
  • Light Rescue & Extrication – using techniques in a safe and effective manner

As part of your job role, you will gain the knowledge of:

  • Core Knowledge – key values, personal development
  • Moving & Handling, Light Rescue, Extrication & Environmental Safety
  • Assessment & Physiological Measurements, Administration of Medications, Treatment & Intervention, Safe discharging & referrals
  • Mental Health, Mental Capacity, Dementia & Learning Disability, End of Life & Bereavement
  • Intermediate Life Support & assisting the registered practitioner
  • Driving & electronic communication

The occupational profile, assessment plan, skills and knowledge for the APP apprenticeship help you understand these and other competencies in more detail. These three documents are key to understanding what you should do to prepare for the end-point assessment.

Associate Ambulance Practitioner vendor exams & assessments

As an Associate Ambulance Practitioner, you will need to equip yourself with the knowledge of all the ins and outs of the job. The vendor exams will test your understanding of the job:

  • Core Skills, Knowledge, Values & Behaviours – Interview (Professional Discussion) using Portfolio Submission
  • Patient Assessment & Measurements – Objective Structured Clinical Examination
  • Intermediate Life Support & assisting the practitioner – Objective Structured Clinical Examination
  • Safeguarding & Capacity (Behaviours) – Situational Judgement Assessment
  • Driving Pictorial – Examination

To demonstrate that you understand the knowledge covered on the level 4 APP apprenticeship you must achieve 40% and over in all assessments. During the apprenticeship, you will be completing a portfolio with written evidence of your on the job learning and CPD.


As you can see, the level 4 APP is an excellent starting point for anyone looking to pursue a career within the healthcare system. The core skills covered in the apprenticeship will open up a wide range of job opportunities. This apprenticeship lets you learn valuable skills while being paid in a practical environment that will give you a wealth of experience that you would have missed out on in a classroom. Employers are keen to use apprenticeships to shape how their employees learn and progress. The type of job roles that require these in-depth skills are endless even military roles are a possible career path.

Read about other apprenticeships here