Junior Regulatory Affairs Associate
- London, ENG (GBR), Brentford, England (GBR)
- £12 - £14.5 Per Hour
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00078434
- Pharma - Regulatory Affairs
- degree
- manufacturing
- process improvement
- strong communication skills
- medical device
Job description
Posted 22 July 2019
Junior Regulatory Affairs Associate
GSK House, Brentford
12 Month Contract
Pay: up to £14.50 per hour
Job Purpose
- To help ensure that existing UK Product Licences are maintained and new Marketing Authorisations are obtained to allow continued and future sale of categories of Consumer Healthcare products in the UK.
- To help ensure that all regulatory activity for a specified portfolio of products is planned and geared to commercial requirements.
- To help ensure that all cosmetic products are sold in compliance with the Cosmetics Directive, that all medical devices are sold in compliance with the Medical Device Directives and that all pack and promotional copy complies with regulations and Codes of Practice.
Key Responsibilities
- To support the Regulatory Affairs group with all general filing, archiving, database maintenance and as well as departmental administrative requests.
- To support the Regulatory Affairs team for marketed and development products and to be aid in progressing the regulatory status of these products in UK & Ireland in such a manner as not to interfere with the marketing and the development activities of the business.
- To prepare submissions which are both accurate and high quality and ensure all files and databases are effectively managed.
- To be responsible with the support of a Regulatory Manager for advising marketing and GMS on the regulatory implications of technical changes
- To develop knowledge of the regulations and guidelines and working practices of the EC and UK & Ireland Regulatory Authority.
- To develop knowledge of PAGB Codes and advertising regulations for OTC medicines.
- To have some knowledge of the Medical Devices Directive, Cosmetics Directive and PIPs
- To help ensure that all pack copy complies with the MHRA and HPRA approved version and to manage instigation following an approval.
- Identifies, challenges, develops and implements written procedures (e.g. local SOPs, work instructions), and proactively highlights opportunities for process improvement.
- Responsible for highlighting own training needs and working with his/ her manager to develop a training plan and achieve training goals.
Business Skills & Competencies
- Degree in pharmacy, chemistry or life science
- Ability to work under limited supervision and prioritise work load accordingly
- Demonstrate ability to show attention to detail
- Good customer focus and team player who has the ability to work with a large group of people
- Strong interpersonal and written communication skills with the ability to communicate effectively across business functions.
- Strong IT skills and ability to work with a variety of systems
BehavioralSkills & Competencies
- High learning agility, and has the ability and willingness to deal effectively with first-time situations or changing conditions.
- Self-reliant, flexible, with good time management skills with ability to operate in an empowered environment with moderate guidance.
- Be able to demonstrate highly effective oral and written communication skills at all times. Capable of delivering key communications with clarity, impact and passion.
- Prioritises work to remain focused on objectives in rapidly changing circumstances.
- Ability to identify and clarify problems for assigned tasks and implement appropriate solutions.
- Team player and ability to work in a matrix environment.
- Demonstrates the flexibility to manage multiple projects in complex virtual /global environments and ability to work within cross-functional teams.
- For all products, collaboration with Quality, marketing, planning, manufacturing and R&D requires a good communicator with an ability to clearly prioritise work in accordance with business needs.
- Ability to partner, influence, network and negotiate with key internal / external stakeholders.
Additional information about the process
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.
