Regulatory Manager

Site Name: UK - Surrey - Weybridge Posted Date: Jul 15 2022 Consumer Healthcare have a new role for a Regulatory Manager Job Purpose Section: 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 Consumer Healthcare products in the UK and Ireland. Provision of an effective regulatory service to allow OTC medicines, medical devices and cosmetic products to be legally sold in UK and Ireland with strong claims which can be supported. 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. Key Responsibilities: 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 either independently on Regulatory Strategy or with Category Regulatory Representatives, to 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 Why you? Qualifications & Skills: Relevant experience in Regulatory Affairs, (including OTC regulatory experience), and with an excellent knowledge of European medicinal, medical device and cosmetic regulatory requirements and previous experience with electronic regulatory submissions and document management systems. 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. Strong customer focus and good team player who has the ability to work with a large group of people and an excellent communicator who ensures that marketing expectations are met with ongoing communication. 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. Preferred Qualifications & Skills: 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. 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. Track record of delivery against objectives and deliverables. Strong leadership skills with proven ability to influence, network and negotiate with key internal / external stakeholders. Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV 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 Why Consumer Healthcare? Right now, we’re on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It’s about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge, and expertise, we’re uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special. Diversity, Equity, and Inclusion In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. New Consumer Healthcare HQ: Recently we’ve shared some exciting proposals with our colleagues which mark an important moment in our preparations for separation and becoming a new, standalone Consumer Healthcare company. Our preparations are going well. GSK is on track to separate in mid-2022 and create two incredible new companies, each with the ability to improve the health of millions of patients and consumers worldwide, and both great places to work. We’ve already confirmed that our new Consumer Healthcare company will be headquartered in the UK and the first step we’re taking is to announce proposals to move our CH business from our current location in GSK House in Brentford when we separate, into a new, CH headquarters in Weybridge. This will be a temporary, but important move in the short term, whilst we take this opportunity to design for the future and create an inspiring, flexible, collaborative workspace that meets the changing needs of our people and our business needs. Inspired by our new culture and purpose, and with a commitment to our sustainability goals, we plan to build a new campus close by which would be home to our headquarters teams, our UK business, our global Oral Health category, R&D and innovation teams, as well as a state-of-the-art Shopper Science lab. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email [email protected] As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. 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