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Regulatory Associate, Infant/Toddler Nutrition

Description

Key responsibilities:
•    Represent the Regulatory function within the Nutrition multi-functional team. You play a key role in representing the Regulatory Function with end-to-end oversight and responsibilities. 
•    Manage a complex and diverse set of registration/regulatory requirements across multiple markets to enable strategic global pipeline delivery. 
•    Develop and deliver innovative global regulatory strategies
•    Bias towards action, to deliver the regulatory strategy. 
•    Ability to translate complex regulatory information into a compelling stakeholder friendly language.
•    Work collaboratively with team, in order to define and implement the regulatory strategy & global registration dossiers.
•    Drive impactful claims and messaging through science support to enable product communication in a compliant manner.
•    Provide regulatory strategy assessments of internal and external opportunities in concert with appropriate technical and regional/local regulatory input.
•    Working with country regulatory, support and where necessary lead Health Authority meetings/negotiations in support of submission and approval of strategic new product registrations in critical markets.
•    Work in partnership with the local regulatory teams to identify and be aware of key requirements and that they are taken into account to deliver a ‘right first time’ approach to new product development. 
•    Influence externally where appropriate industry led regulatory reviews and initiatives of direct relevance to Reckitt, in-line with Reckitt’s strategic vision.  
•    Take the regulatory lead in the preparation of responses to address significant safety, regulatory and PR issues in the assigned Category, including support internal investigations into allegations of non-compliance 
•    Devise, and deliver to business partners, training materials that optimally prepare the business for the present and future regulatory environment.  
•    Ensure through dynamic resourcing that appropriate support is given to the Innovation and compliance projects & team. 
•    Support work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling both compliance and speed to market.

Ideal Experience:
•    Education in a nutrition related scientific field or equivalent experience
•    Experience in developing Regulatory strategies
•    Knowledge of dossiers and technical file creation and global registrations.
•    Experience in Regulatory Affairs 
•    Knowledge of the global regulatory environment for Nutrition products and how it impacts regulatory dossiers and registration.
•    Experience in preparing and submitting dossiers, variations and renewals. 
•    Understanding of global product development practice, rules, regulations and guidelines.
•    Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries. 
•    Ability to consistently deliver to time, cost and quality standards in a high pressure environment 
•    Good communication skills and the ability to educate on complex regulatory situations to non-regulators 

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; 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. 


Nearest Major Market: New York City
Nearest Secondary Market: Newark

Job Segment: Nutrition, Healthcare

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