Global Regulatory Manager - Switch ( FTC 12 Months)

Description

Want to show a global leader what’s possible? As Global Regulatory Manager - Switch ( FTC 12 Months) you’ll stretch your expertise and have the freedom to find new ways to make people’s lives better. 
 

Global Regulatory Manager - Switch ( FTC 12 Months) 
Kingston upon Hull, East Yorkshire, Hybrid Working  
Competitive Salary & excellent benefits package: 25 days Annual Leave, Bonus, Private Health Cover

The Global Switch Manager will evaluate novel ways to present evidence-based benefit /risk data, using local insight, clinical evidence, education programmes, RWE and digital/device data to build compelling and meaningful support for switch submissions.  You will work closely with the Reckitt Policy team to define and target appropriate influencing opportunity globally to support OTC reform and engagement to support successful switch submissions. Accountable for the delivery of the product switch dossier, making sure there is appropriate regulatory resource and expertise when working to deliver the switch submissions.
 

Key responsibilities:
•    Manage a complex and diverse set of regulatory requirements across multiple markets to enable strategic switch delivery
•    Develop and deliver innovative global regulatory strategies to support switch initiatives.
•    Drive development and be responsible for delivery of category specific switch plans.
•    Identify and evaluate specific candidate switch molecules for Reckitt existing brands and new category areas.
•    Lead work required to define regulatory switch process and procedures to optimise accuracy and efficiency.
•    Ability to translate complex regulatory information into a compelling stakeholder friendly language.
•    Work collaboratively within R&D cross functional community to define global switch dossiers requirements and documentation. 
•    Provide strategic switch assessments of internal and external commercial opportunities in concert with appropriate medical and regional/local regulatory input.
•    Working with LRA, support and where necessary lead Health Authority meetings/negotiations in support of submission and approval of strategic new switch in critical markets
•    Work in partnership with the local regulatory teams to identify and be aware of key requirements and insights, that they are considered to deliver ‘high quality’ switch packages. 
•    Influence externally where appropriate industry led regulatory reviews and initiatives of direct relevance to RB portfolio, in-line with RB’s strategic switch plans.  
•    Take the regulatory lead in the preparation of responses to address significant safety, regulatory and clinical issues for the assigned switch.  

You’ll succeed because… …you’ve a scientific background and you understand Regulatory Affairs. Ideally you will have: 
•    Demonstrated proficiency at leading complex multi-faceted projects and managing cross functional teams 
•    Demonstrated understanding/experience in key functional areas: New Product Development, Regulatory Affairs, Drug Safety, Medical Affairs, Clinical Affairs
•    Understanding of global product development practice, rules, regulations, and guidelines.
•    Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.

Equality

At Reckitt, we recognise that in real life, great people don’t always ‘tick all the boxes’. That’s why we hire for potential as well as experience. Even if you don’t meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. Come and join a team whose purpose is to protect, heal and nurture in the relentless pursuit of a cleaner and healthier world.

All qualified applicants to Reckitt will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.