Summary
Our Regulatory Affairs Specialist will support the busy function, responsible for developing and implementing strategies that allow the company to legally develop, manufacture, market and supply our portfolio of products. Alongside your role, you will undertake the 3-year Regulatory Affairs Specialist Apprenticeship (Level 7) Apprenticeship.
Wage
£30,000 a year
Training course
Regulatory affairs specialist (level 7)
Hours
Hybrid working - we spend three days of your choice in the office, with the remaining days working at home.
38 hours a week
Possible start date
Tuesday 1 July
Duration
3 years
Positions available
1
Work
As an apprentice, you’ll work at a company and get hands-on experience. You’ll gain new skills and work alongside experienced staff.
What you’ll do at work
* Work with colleagues in the department to establish how changes in product regulation will impact our products
* Act as the named Regulatory Affairs contact on compliance and product development projects - this could be supporting a product reformulation, changing how we manufacture or test our products
* Work with colleagues across the business to form strong partnerships - by helping colleagues to understand the impact of changing regulatory requirements, our obligations as a company, and working to understand their challenges and how we can help them
* Engaging with regulatory authorities, trade associations, and external technical service providers
* Helping the team prepare and submit product dossiers to achieve timely authority approvals
* Helping improve how we work - taking the lead on process improvement initiatives
* Celebrate successes! As the team responsible for ensuring regulatory compliance of a diverse portfolio, we face many regulatory and technical challenges - sharing our successes with the wider company allows us to demonstrate the value the team brings to the organisation
Where you’ll work
Linthwaite Nr Huddersfield
HD7 5QH
Training
An apprenticeship includes regular training with a college or other training organisation. At least 20% of your working hours will be spent training or studying.
College or training organisation
THE ORGANISATION FOR PROFESSIONALS IN REGULATORY AFFAIRS LIMITED
Your training course
Regulatory affairs specialist (level 7)
Equal to master’s degree
Course contents
* Simultaneously coordinate and plan multiple activities/projects in a highly regulated environment, ensuring completion to time, within budget and to an acceptable quality. Deal with complex issues both systematically and creatively.
* Seek and use evidence-based strategies to take decisions in the absence of complete data and in complex and unpredictable situations impartially, fairly and on merit, without bias in an open and transparent manner. Recognise when it is appropriate to refer the decision. Think critically, take accountability and lead decision making processes, outlining any omissions and justifications of the decisions taken.
* Recognise negotiation strategies and use them with direct and diplomatic approaches, obtaining and maintaining the trust and respect of other stakeholders whilst managing complex interdependencies.
* Engage in research and the evaluation of data to assess its suitability to support risk and safety arguments in a structured and logical manner; alert stakeholders to gaps in evidence. Create and offer alternative approaches to mitigate and manage risk where required. Manage the development and application of evidence-based strategies for operational plans. Demonstrate self-direction and originality in problem solving, practise with a high level of autonomy.
* Develop and deliver high level materials that present and communicate complex research information and data analyses to a wide variety of audiences in different settings and through multiple media. Written and oral communication that is effective when influencing, negotiating, facilitating and resolving conflicts in risk and safety management with stakeholders. Develop and deliver management level presentations which resonate with senior stakeholders, both business and technical.
* Research and organise data from various sources, storing the results in a way that optimises retrieval. Develop and manage a network of contacts to share appropriate information and advice. Know when to share information and who to share it with. Use knowledge to improve the efficiency of work where possible.
* Work autonomously on specific areas of responsibility, in particular leading the development and implementation of the regulatory strategy, whilst interacting with colleagues to contribute to the delivery of project outcomes, recognising the contribution of other functional team members.
* Select and use appropriate and required IT systems in support of the regulatory function.
Your training plan
Alongside your role as the Regulatory Affairs Specialist, you will undertake the 3-year Regulatory Affairs Specialist Apprenticeship (Level 7) Apprenticeship to achieve your qualification through a mixture of on-site and online academic learning through TOPRA (The Organisation for Professionals in Regulatory Affairs).
Requirements
Essential qualifications
Degree in:
* Life Sciences, Engineering or Technical (grade 2:2)
Let the company know about other relevant qualifications and industry experience you have. They can adjust the apprenticeship to reflect what you already know.
Skills
* Communication skills
* IT skills
* Attention to detail
* Organisation skills
* Problem solving skills
* Presentation skills
* Analytical skills
* Logical
* Team working
* Initiative