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.
Responsibilities:
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.
Skills:
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
Behaviours:
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.
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.
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.
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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Two engineers working together on a partially disassembled jet engine of a small airplane in an aircraft maintenance hangar.
Why should you pick this apprenticeship?
If you have a passion for engineering and are
looking for a rewarding career that offers hands-on training and the
opportunity to earn while you learn, then the Level 7 Power and Propulsion Gas
Turbine Engineer Apprenticeship may be the perfect choice for you.
This
apprenticeship program is designed for those who are interested in pursuing a
career in gas turbine engineering, specifically in the fields of aviation and
marine propulsion. As an apprentice in this program, you’ll receive on-the-job
training from experienced professionals and will gain the skills and knowledge
necessary to become a highly skilled engineer in your chosen field.
Unique Aspects
One of the unique aspects of this
apprenticeship program is the opportunity to work with cutting-edge technology.
Gas turbines are an essential component of aviation and marine propulsion
systems, and the industry is constantly evolving. As an apprentice in this
program, you’ll be at the forefront of these advancements and will be able to
work with some of the most advanced technology in the world.
Another
significant benefit of this apprenticeship program is the potential for
long-term career prospects. Once you’ve completed your apprenticeship, you’ll
be highly skilled in your chosen field, and your experience will make you a
valuable asset to potential employers. Many apprentices go on to secure
long-term employment with the companies they trained with, or move on to other
companies in their industry, taking their valuable skills with them.
Furthermore, this apprenticeship program
offers a clear path to professional registration with the Engineering Council.
This professional registration demonstrates to potential employers that you
have achieved a high standard of technical and professional competence, giving
you an edge in the job market.
What will you be doing?
As a Power and Propulsion Gas Turbine Engineer, your work will challenge you to bring together the conflicting requirements of operational or technical constraints that include engine reliability, efficiency, and emissions, alongside the economic viability of operations. You may be required to achieve overall good efficiency at the expense of favorable reliability or to implement technological improvements that increase efficiency but not necessarily emissions.
Conclusion
In conclusion, a
Level 7 Power and Propulsion Gas Turbine Engineer apprenticeship offers an
excellent opportunity for anyone interested in this field. The apprenticeship
will equip you with the necessary skills and knowledge to become a highly
skilled specialist with fundamental and applied knowledge of engineering
related to the design, performance, operability, and maintenance, and the
selection of gas turbine engines. You will have the opportunity to work on
challenging projects, interact with specialists of different aspects of
engineering design and operations, and be responsible for the provision of
services and solutions relating to in-service fleet support, lifecycle cost
reduction, engine modifications, and life extensions.
Do you consider yourself a problem solver? Are you interested in using your mathematical skills to progress into a highly regarded professional career? Well look no further. Our Level 7 Actuary Apprenticeship may just be the perfect fit for your career!
Job Overview
The Actuarial industry is a diverse field with a wide range of job opportunities including working in areas of insurance, healthcare, pensions, corporate finance, and banking. Actuaries use their problem solving and strategical thinking skills alongside their mathematical skills to analyse the financial impact of various events and managing risk. Actuaries are also responsible for developing and implementing policies and procedures that help businesses and individuals make informed decisions. They analyse data and create mathematical models which they use to evaluate future financial risks to their clients. Actuaries must act in the public interest and therefore must adhere to the highest standards of professional conduct and competence; Maintaining ethical conduct and integrity. Much of this is taught in the Actuary apprenticeship – Level 7.
Entry Requirements/ Qualifications for Actuary Apprenticeship
Employers may have their own set of entry requirements but majority are flexible. Generally, apprentices are expected to have a numerical degree (Mathematics, Chemistry, Physics, Engineering) or a degree in a non-numerate subject accompanied with a Grade B in A-level Maths or equivalent; or to have previously completed a Actuarial Technician Apprenticeship (Level 4) and gained a qualification.
Compulsory: If apprentices do not hold both Level 2 English and Maths they are required to before taking their end-point assessment.
Skills, behaviour and knowledge for Actuary Apprenticeship
Below are a variety of skills, knowledge and behavior that candidates should have for this apprenticeship:
Skills:
Using different tools and methods to make informed decisions
Able to effectively interpret clients’ accounts and financial statements
Have the expertise to build a model, analyse the data collected and the methods that were used and final outputs. This should all be documented for future use
Should communicate effectively with their clients and other individuals who do not have specialist actuarial expertise. They should also use effective structure and language to explain their concepts
Should be able to communicate the results of their work, the approach they took and their final conclusions with a senior actuary
Able to apply actuarial techniques analyse risks and produce solutions to present to the team
Knowledge:
Candidate has an understanding of mathematical and statistical techniques that is related to actuarial work.
Able to summarize data using statistics and graphical presentations
Understanding the principles of modelling such as deterministic models, survival models and other models used in actuarial work
Being aware of what is needed for an effective model and methods that are used to model cash flow
The key fundamentals of corporate finance and technologies used to manage risk.
Economic principles e.g. microeconomics and macroeconomics and how this can be applied to businesses
Able to use and understand risk management techniques/processes that actuaries are required to know
Understanding internal and external business environment, business culture and teamwork
Behaviour
Taking ownership of your own professional & personal development
Following the Actuaries Code in all tasks internally and externally
Being professional and ethical in all actuarial work
Able to work effectively within a team
Works effectively to ensure all work is completed in time (can communicate with team if not possible)
Further Information
The duration of this apprenticeship is 36 months and this does not include the End-point assessment (EPA). For further information on the EPA process please click here.
Professional Development and Progression
Before apprentices go through gateway, it is compulsory to complete the Personal and Professional Development requirements of the IFoA Associateship level and pass IFoA exams. Once the apprenticeship is successfully completed they are then eligible to apply for the Associateship membership of the IFoA. They will have the full expertise of an Actuary and this will provide them with the requirements needed to progress into Fellowship of the Institute and Faculty of Actuaries.
Conclusion
The Level 7 Actuary Apprenticeship is perfect for those who want to continue to progress in their career and taking on the challenge of learning while earning! The skills and knowledge that are developed during this apprenticeship will give you a stepping stone to reach your goal and prepare you for the work that is done within the Actuary field of work. Not only will you have a qualification but you will also have experience of working within the industry and experience is one of the major things employers look for! Starting a new career can be stressful but with the help and support provided at Apprentice Now you will receive constant support.
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Does solving complex engineering challenges by overseeing the engineering, business and management parts of a system or project sound exciting to you? Then a Level 7 Systems Engineer Apprenticeship might be the program to start your professional career!
In this article, you will find information on the following points (click on any of them to go straight away to that part):
Systems engineering is a multidisciplinary field that combines the responsibilities of engineering and management. It is a process that defines, plans, and implements the projects for the development, integration, operation, and maintenance of systems.
The most common form of systems engineering is project-based. It revolves around major projects such as transportation infrastructure development and environmental protection projects. The other form of system engineering is product-based, and it focuses on designing and developing products like computers or coffee makers.
1.2. Who is it for?
Level 7 apprenticeships are equivalent to a masters degree, so this apprenticeship standard is for self-motivated graduates with an upper second class or higher award in an electronic engineering or another science degree.
1.3. What does a Systems Engineer do at work?
As a Systems Engineer apprentice you will work closely with project
managers and employees from business development and/or sales teams. You might
be responsible for building and managing teams of skilled workers and
specialists in scientific and technological areas.
As a Systems Engineer you may also have a customer-oriented role, to supervise the system and make sure that it meets customer and user needs and expectations.
1.4. What jobs can you get with a Level 7 Systems Engineer Apprenticeship?
People who choose this career often hold jobs like: Lead Engineer, Project Engineer, Technical Lead, Acquisition Engineer; Systems Engineer; Test Engineer; Requirements Engineer; Requirements Manager, Systems Architect, Systems Designer, Systems Analyst, Engineering Manager, Systems Specialist, Technical Manager, in-service Engineer, Through-life Systems Engineer, Operation and Support Engineer, Acceptance Engineer, Integration Engineer, Interface Manager.
2. Key duties of a Systems Engineer (Level 7) apprentice
As part of your job role as a Systems Engineer, you will perform tasks and duties that will allow you to meet certain competencies. Some of these key duties will be:
Define and manage the system lifecycle for a
project
Define and manage project requirements
Manage project risk
Model and analyse systems
Generate solution concepts
Architect and design systems
Plan and manage systems integration
Plan and execute system verification and
validation
Provide technical leadership within a project
Support transition of the system into the
operational environment
Provide systems-level in-service support of the
system
Support technical aspects of project management
Take responsibility for configuration and data
management
Co-ordinate technical outputs and work of
multi-disciplinary teams
3. Knowledge, skills, behaviours of a Systems Engineer (Level 7)
There are several knowledge, skills and behaviours that are required of a systems engineer. Throughout your apprenticeship you will develop and improve each one of these. To see the complete lists, visit Institute for Apprenticeships’ “Systems Engineer Degree” page.
3.1. Knowledge required to be a Systems Engineer
K1. Systems engineering lifecycle processes.
K2. The role a system plays in the super system
of which it is a part.
K3. The characteristics of good quality
requirements and the need for traceability.
K4. The distinction between risk, issue, and opportunity
and the different forms of treatment available.
K5. The benefits and risks associated with
modelling and analysis.
K6. How creativity, ingenuity, experimentation
and accidents or errors, often lead to technological and engineering successes
and advances.
K7. Different types of systems architecture and
techniques used to support the architectural design process (i.e. the
specification of systems elements and their relationships).
K8. Non-functional design attributes such as
manufacturability, testability, reliability, maintainability, affordability,
safety, security, human factors, environmental impacts, robustness and
resilience, flexibility, interoperability, capability growth, disposal, cost,
natural variations, etc.
K9. Integration as a logical sequence to confirm
the system design, architecture, and interfaces.
K10. Interface management and its potential
impact on the integrity of the system solution.
3.2. Skills required to be a Systems Engineer
S1. Select appropriate lifecycle for a system or
element of a system and establish its lifecycle stages and the relationships
between them.
S2. Define context of a system from a range of
viewpoints including system boundaries and external interfaces.
S3. Use appropriate methods to analyse
stakeholder needs to produce good quality, consistent requirements with
acceptance criteria and manage them throughout system development.
S4. Identify, analyse, recommend treatment, and
monitor and communicate risks and opportunities throughout project.
S5. Generate a physical, mathematical, or
logical representation of a system entity, phenomenon or process.
S6. Apply creativity, innovation and problem
solving techniques to system development or operation.
S7. Define the systems architecture and derived
requirements to produce an implementable solution that enables a balanced and
optimum result that considers all stakeholder requirements across all stages of
the lifecycle.
S8. Identify, define, and control interactions
across system or system element boundaries.
S9. Assemble a set of system elements and
aggregate into the realised system, product, or service using appropriate
techniques to test interfaces, manage data flows, implement control mechanisms,
and verify that elements and aggregates perform as expected.
S10.
Define verification plans (including tests) to obtain objective evidence that a
system of system element fulfils its specified requirements and characteristics.
3.3. Behaviours that a Systems Engineer should demonstrate
B1. Adopt and encourage within the team an
holistic thinking approach to system development.
B2. Perform negotiations with stakeholders
recognizing different styles of negotiating parties and adapts own style
accordingly.
B3. Adopt and encourage within the team a
critical thinking approach using a logical critique of work including
assumptions, approaches, arguments, conclusions, and decisions.
B4. Take personal responsibility for health and
safety practices and sustainable development.
B5. Operate with integrity and in an ethical manner
and ensure that team members perform with integrity and in an ethical manner.
B6. Take a proactive and systematic approach to
resolving operational issues.
B7. Maintain awareness of developments in
sciences, technologies and related engineering disciplines.
4. Entry criteria for a Level 7 Systems Engineer Degree
Each employer and academic training provider can have their own entry criteria. What would normally be expected from the apprentice is to have already achieved:
a level 5 STEM qualification and 5 years relevant experience
or
a level 3 or 4 STEM qualification and 10 years relevant experience.
5. Qualification and link to Professional Recognition after completion
After completion of the apprenticeship program, you will get awarded a master’s degree in Systems Engineering.
You will also achieve the standard of Practitioner against a selected profile of the International Council on Systems Engineering (INCOSE) competencies.
Finally, the program will also provide you with a route towards the knowledge, experience and competence required to apply for recognition by INCOSE as a Certified Systems Engineering Professional (CSEP) and to apply to be registered by the Engineering Council as a Chartered Engineer (CEng).
6. Conclusion
The Level 7 Systems Engineer apprenticeship is a great program to take your career to the next level, by increasing your knowledge and skills in systems engineering.
With its completion, you will get awarded a masters degree, and be able to efficiently take roles as a Lead Engineer, Project Engineer, Technical Lead, Acquisition Engineer, Systems Engineer, Test Engineer, etc.
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