Regulatory Affairs OTC Category Manager
vor 3 Wochen
The purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all regulatory requirements are met for both innovation and existing products according to the company Values. An individual may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role may require the individual to provide specialist regulatory advice across the Category and Function.
- Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug / cosmetic / devices / food and supplements (dependent on category) development and regulatory requirements as appropriate
- Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC/BU/Region regulatory teams
- Communicates effectively within the function at all levels and within cross-functional Project Teams
- May supervise or mentor other team members
- Plans, prepares and delivers high-quality regulatory files to agreed timelines
- May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to company's competitive advantage
- May act as company representative to external groups on specific task forces within their field of expertise
- 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 CAP meetings and tools
- In conjunction with the category regulatory CMC lead, ensure support 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
- Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions
- BA or BSc in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
- Position requires practically-applied demonstration of intellect and an ability to interface effectively with R&D, supply chain and commercial counterparts with credibility
- 5 to 6 plus years’ experience in Regulatory Affairs
Care to join us. Find out what life at Haleon is really like 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.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.Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.
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Regulatory Affairs OTC Category Manager
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Nyon, Schweiz Haleon VollzeitThe purpose of this role is to provide regulatory management, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/BU/Region and ensure all...
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