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Global Regulatory Affairs Senior Manager - Health Relief

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Research & Development
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United Kingdom
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RB 

 

Recruitment image Start Date: 7th November 2018

Close Date: 7th December 2018

Location: Hull

Competitive Salary & Benefits 

 

 

 

The Global Regulatory Health Manager will be responsible for the management of the team working on creation and delivery of core dossiers/technical files. For categories with defined classification, the Health manager may take a leadership role in the strategic direction for the R&D and CDO teams in support of the assigned category. Along with the senior Manager/Director, you will be accountable for the end to end creation and delivery of ‘right first time’ product core dossier/technical files ensuring the achievement of in market registrations/launches, on time and in line with the agreed regulatory strategy and business priorities.

 

 

 

You will support the senior Manager/Director for the assigned Respiratory brand (Strepsils) and associated defined classifications and ensure development of regulatory project plans to drive regulatory expertise and understanding throughout the project.

 

 

 

You will enable delivery of NPDs to global markets by providing key skills and expertise in dossier creation, working with the senior manager to ensure an integrated approach to regulatory planning across innovation and ensure priorities are aligned with the agreed portfolio strategy.

 


Working with the GRA Director /Senior Manager you’ll help shape future policy, gather, disseminate & assess regulatory & regulatory competitive intelligence for assigned brands.

 

 

 

Wide stakeholder management across Category R&D, HME, Innovation, Local Regulatory teams, Supply and Marketing functions

 

 

 

Your key responsibilities will include:

 

 

 

·        Effective project management & building of key knowledge base within GRA to ensure ability to define the data required for the dossier/technical file to deliver a ‘right first time’ approach to new product development.

 

·        Accountability for building best practice and skill base for project management of Regulatory NPD requirements & dossier/technical file creation in line with the project strategy

 

·        Support strategic leadership of global consumer product development and registration projects for their category to meet the business objectives

 

·        Develop and deliver innovative global regulatory strategies in their category across all markets.

 

·        Ability to translate regulatory information into stakeholder friendly language

 

·        Influence externally where appropriate industry led regulatory reviews and initiatives of direct relevance to RB, in-line with RB’s strategic vision. 

 

·        Take the regulatory lead where appropriate in the preparation of responses to address significant safety, regulatory and PR issues in the assigned Category  

 

·        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.

 

·        Devise, and deliver to business partners, training materials that optimally prepare the business for the present and future regulatory environment. 

 

 

 

Is this you?

 

 

 

 

 

·        Educated to honours degree level in a scientific field or equivalent experience

 

·        A solid track record of Regulatory management experience gained from the FMCG industry and knowledge in NPD and dossier/technical file creation and global registrations.

 

·        Experience in different regulatory classifications (where appropriate)

 

·        Technical Competencies:

 

o   Knowledge of the Regional and Global regulatory environment and how it impacts regulatory dossiers and registration

 

o   Experience in preparing and submitting dossiers, variations and renewals. 

 

o   Ability to communicate requirements

 

o   Understanding of global product development practice, rules, regulations and guidelines.

 

o   Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries. 

 

o   High level of accuracy in reviewing and authoring documentation

 

·        ability to consistently deliver to time, cost and quality standards in a fast-paced environment

 

·        Knowledge of submission processes and product life cycle management activities for various consumer product categories.

 

·        Ability to work with multiple stakeholders, managing the relationship and building trust in a wide range of environments and cultures.

 

·        Strong quality and compliance orientation has a clear understanding of regulatory compliance issues and the potential impact of compliance related issues on meeting key deliverables.

 

 

 

 

 

 

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