Regulatory Affairs Sr. Manager - Oral Health

Job Description

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne,Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And aculture that’s uniquely ours. Care to join us. It isn’t a question.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.About the Role:The purpose of this role is to provide regulatory leadership & expertise to drive cutting edge innovation for the company’s portfolio of world class Dental Appliance Care brands. In this role the individual will build a network and actively manage close& collaborative relationships with Commercial partners, cross-functional R&D teams and local in-market regulatory teams to devise creative regulatory strategies for new product launches and to support the existing products on the market.Key Responsibilities

• Acts as a Business Partner and provides regulatory advice across sub-category on all aspects of product development and regulatory requirements for portfolio of medical device products.
• Provides regulatory expert advice with route to market & claims development for a sub-category. Develops novel regulatory strategies and influences approaches to secure competitive approvals and speed to market in conjunction with LOC/BU/Region regulatoryteams.
• Communicates, influences, and negotiates effectively with cross-functional internal and external groups at all levels.
• May lead an efficient and well-motivated small team; including effective people development.
• Ensure appropriate prioritization and resourcing of projects and works within regulatory, product development, supply chain and tech excellence to assure alignment of registration strategy for all new or modified formulations and high quality of submissionpackages. Ensures regulatory requirements are considered in the project plans. Leverages experience across regions for the allocated projects/products and provides regulatory advice on a global basis.
• Leads non-product related initiatives, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to companys competitive advantage.
• Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines. May act as company representative to external groups for specific topics (e.g. national or pan-national trade associations).Provides support to local Regulatory Affairs in interactions with local Regulatory Agencies and experts. May interact directly with local Regulatory Agencies.
• Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within the copy approval meetings and tools.
• Accountability for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence Oversees compliance in all actionsby ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.

Qualifications & Skills:We are looking for professionals with these skills to achieve our goals:Minimum requirements:

• BA or BSc in Life science/Pharmaceutical related science (e.g. Chemistry, Pharmacy, Biochemistry)
• 5 years of experience in a related Regulatory Affairs role with a broad knowledge of requirements for regulated products
• Experience of regulatory affairs in medical devices, plus either cosmetics or medicines.
• Knowledge of regulatory strategy for filing of submissions at a global level
• Proven experience in engaging with & influencing stakeholders
• Track record of strategic thinking and looking at how to improve ways of working

Preferred Qualifications:

• RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP in Regulatory Affairs, Pharmacy
• RAPS qualifications

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.Diversity, Equity and Inclusion At Haleon 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.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. Care to join us. Find out what life at Haleon is really like careers/At Haleon 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. Were strivingto 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. We believe in an agileworking culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opp