Regulatory Affairs Manager/Regulatory Affairs Executive, Open to flexibility
Regulatory Affairs Manager/Regulatory Affairs Executive, Open to flexibility
We have a FANTASTIC opportunity for a talented Regulatory Affairs Manager/Regulatory Affairs Executive to join our team in London! In this role, you will not only learn everything there is about regulatory affairs, but you will be given a chance to manage your own portfolio of products. You will provide effective regulatory service to allow OTC medicines, medical devices and cosmetics products to be legally sold in the UK and Ireland.
Apart from the above, your job purpose will be to:
- To manage a defined portfolio of products within the GB&I Regulatory Affairs Group to ensure proactive and timely compliance with all UK, Irish and European legislation and ensure that all regulatory activity is planned and geared to support and deliver commercial requirements.
- To identify and communicate regulatory issues which have the potential to affect the competitive impact of GlaxoSmithKline Consumer Healthcare products in the UK and Ireland.
- To ensure all regulatory maintenance activity, pack copy and advertising for the GB&I business is managed to comply with the regulations and relevant company requirements.
Still interested? Keep on reading, it gets only better!
Your responsibilities will include:
- Responsible for ensuring that medicinal, medical device and cosmetic products can be legally sold and supported in compliance with regulations.
- Provide advice, recommendations and support for product claims, copy and labelling.
- Responsible for ensuring that all personnel are given adequate training and guidance in all aspects of regulatory affairs work, and to ensure that all regulatory systems and databases are up to date and effectively managed.
- Ensures quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines. Responsible for the maintenance activities associated with a defined portfolio, including product renewals, and routine PV activity.
- Sets and resets priorities in rapidly changing circumstances and works with other team members to maintain focus and deliver objectives.
- Creates and maintains good working relationships within the Business and across Global Regulatory (GRA) functions, as well as other support functions, including factories and GMS teams, Quality, R&D, and with influential external bodies (Trade Associations and professional bodies).
- Leadership of, preparation and review of day to day submissions with full accountability for delivery. May also take accountability for larger projects as part of a broader project plan i.e. line extensions, global strategic projects, system changes etc.
- Contribute to the assessment of new innovation projects and exploratory product development briefs.
- Working with Category Regulatory Representatives, help develop the regulatory strategy or components of filing strategies designed to minimise time for development and regulatory approval and optimise competitive positioning and global opportunities.
- Required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities and lead regulatory interactions.
- 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.
Does this sound like an ideal role for you? YES?! Make sure you apply before the 27th of September 2018!
NO? If you are still not convinced, make sure to watch the video below:
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Thank you for your interest in this opportunity.
- Degree in pharmacy, chemistry or life science.
- Relevant experience in Regulatory Affairs, (including OTC regulatory experience), and with an excellent knowledge of European medicinal, medical device and cosmetic regulatory requirements.
- An in-depth knowledge of the PAGB Code of Practice is essential, together with an excellent working knowledge of other advertising Codes and labelling guidelines.
- Previous experience with electronic regulatory submissions and document management systems.
- Ability to foster strong matrix working. Facilitates dialogue between team and matrix members so they understand links between their different ideas and perspectives. Brings team members into the discussion so they can contribute their ideas. Capable of developing and recommending strategies for change. Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project.
- Capable of identifying project or team issues in advance and seeking necessary help and support to resolve. Ability to derive creative solutions to regulatory problems, while balancing the expectations of a variety of stakeholders and ensuring compliance with regulation.
- Show a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process.
- Strong organisational and planning ability to organise and prioritise a high volume of work so as to ensure that all regulatory activities meet business targets.
- Demonstrates the flexibility to manage multiple projects in complex virtual /global environments and ability to work within cross-functional teams.
- Strong customer focus and good team player who has the ability to work with a large group of people.
- An excellent communicator who ensures that marketing expectations are met with ongoing communication.
- 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 limited 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.
- Strong leadership skills with proven ability to influence, network and negotiate with key internal / external stakeholders.
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
You may apply for this position online by selecting the Apply now button.
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