Regulatory Affairs Consultant

Role:Regulatory Affairs Consultant

Location:Buckinghamshire

Salary- Negotiable

This role demands the jobholder is able to take initiative and highlight potential solutions to more complex problems with minimal supervision. Besides demonstrating a level of expertise with regulatory issues, this role demands an ability to communicate effective across the team, and also with clients. Should the opportunity arise, the job holder will be required to attend a client site and act as an ambassador for the company, displaying clear communication skills and comprehensive understanding of our organization.

Can act as an Associate (i.e. more junior level), if required.

B. Key Accountabilities and Duties

Under senior management supervision, provides a full range of consulting services (writing, qualitycontrol,training,submission)withinpersonalareaofexpertise. Ensures high quality and on time delivery of consulting services to clients.

Technical duties will include but are not limited to:
• Act as a subject matter expert with regards to regulatory projects, including but not limited

to: -

Demonstrate a sound understanding of and keep up to date with developments with regards to pre- and post-approval regulatory affairs. Become established as a reliable point of contact for sharing knowledge with regards to current guidelines with the team when required.

- Undertake specific projects from scratch, for instance both licence variations and renewals from inception through to completion, ensuring complete accuracy and precision in the production of documentation. Make recommendations for projects when required.

- Complete accurate analysis of projects as required. Verify the accuracy of both documentation and also method, ensuring that suitable recommendations are made to resolve outstanding issues.

- Support the team by assisting in the preparation and submission of regulatory applications as and when required.

- Using own initiative; undertake small research projects as per Company guidelines, in line with business needs when required.

• -  Complete accurate and effective Patient Information Leaflets as and when required.

• -  Complete product information changes, packaging material review, administrative

part of module 1, promotional material review, ATU support.

• -  May act as  share team-lead.

• -  May review work of junior personnel and/or  partners.

- Prepares and/or coordinates submission of applications for Transparency Committee and Pricing Committee and assists in the development of proposals.

• Contribute to the successful delivery of client projects to ensure that key contractually agreed targets, budgets and deliverables meet both business and client expectations. Ensure oversight of ongoing risks and issues over specific client projects and support the Project Manager where necessary to achieve successful resolutions.

Non-Technical duties include, but are not limited to:

• Understand and embody business values and conduct everyday issues with these in mind.

• Remain committed to self-improvement by conducting self-appraisals after all relevant unit tasks, and assess strengths and weaknesses and address these accordingly. Demonstrates a commitment to improvement by maintaining and developing current skill set.

• Demonstrate a sound understanding of Quality Management System processes and procedures ensuring that all work undertaken follows guidelines set out by the business.

• Establish and maintain a personal log of training and skills development with regards to

relevant legislation, guidelines and client practices. In addition, log sources consulted in the

research process so that active learning and development can take place.
• Build effective professional relationships with clients. Communicate clearly and manage

expectations effectively.
• Contribute regularly to team meetings by updating the team on specific areas of work and

skills development.

Key Behavioral Indicators

• Demonstrates a clear ability to achieve results, by showing initiative; completing work correctly with some supervision; consistently making extra effort to complete work; being able to resolve small unexpected problems, or those not usually experienced without difficulty, and completing the job through to the end. 

• Demonstrates a structured, organised and methodical approach to work by managing time effectively; prioritising workload effectively; multi-tasking effectively; using tools and methods for planning and organising and keeping track of time spent on activities. 

• Demonstrates the following flexible attributes when completing work: being prepared to ask for help and clarification when required; remaining constructive under pressure; remaining upbeat and positive; taking feedback constructively; being flexible and adapting quickly to new strategies, methods and goals; being thorough and persistent in face of tough challenges. 

• Demonstrates effective team work by displaying the following behaviours: co-operating by participating willingly in cross-functional team working; helping and supporting others, admitting mistakes and learning from them, communicating progress clearly and concisely to colleagues; being solution-orientated and energetic; showing respect for

Demonstrates a strong customer orientation, builds trust and loyalty and takes responsibility for customer satisfaction. Able to work with complete confidentially and discretion, gives confidence. 

• •

Demonstrates results orientated performance with good technical competence and attention to detail. Has a high work ethic, able to work under pressure and be pro-active; takes action to build relationships 

others’ values and views, listening attentively and retaining information accurately. 

Essential Skills and Abilities

• Microsoft Office trained in Word, Outlook, PowerPoint, Excel

• Regulatory experience gained within a fast-paced environment

• Good organizational skills

• Excellent written and verbal communication skills

• Excellent scientific writing skills

• Very good level in English (Native English speaker or fluent in English)

• Ideally a Graduate with a Life Sciences degree or equivalent qualification as a minimum.