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Global Regulatory Manager, Intimate Wellness

Description

RESPONSIBILITIES:
•    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.
•    Review and approval of technical files under the scope of your accountabilities 
•    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 [where necessary] and deliver innovative global regulatory strategies in their category across all markets.
•    Ability to translate regulatory information into stakeholder friendly language
•    Excels at the strategic and delivery aspects of the role
•    Work collaboratively within stakeholders to define global registration dossiers and technical documentation. 
•    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 where appropriate in the preparation of responses to address significant safety, regulatory and PR issues in the assigned Category   
•    Working with LRA, 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. 
•    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 (Subject Matter Experts) is given to the Innovation projects & team. 
•    Supports work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market.

Description

Want to show a global leader what’s possible? As Global Regulatory Manager, Intimate Wellness you’ll stretch your expertise and have the freedom to find new ways to make people’s lives better. 
 
Global Regulatory Manager, Intimate Wellness 
Parsippany, NJ 
Competitive Salary & excellent benefits package 

 
Leading a team in a fast-paced international business, you’ll play a critical role in driving innovation and developing new products. Responsible for your own category, you’ll:
•    Navigate a complex and changing regulatory environment to ensure our product portfolio strategy supports our ambitious growth plans
•    Anticipate and influence regulatory changes, lead our thinking about what is possible
•    Define global registration dossiers and technical documentation
•    Ensure the safety and efficacy of products. 
 
 

You’ll succeed because… 
…you’ve a scientific background and you understand Regulatory Affairs. You: 
•    Understand new product development, registration and submission processes
•    Have led teams, maintaining a high attention to detail in preparing technical dossiers, variations and renewals
•    Are an excellent communicator, using your expertise to influence others to make fact-based decisions
•    Are results-orientated and entrepreneurial. Just like us. 

 

You’ll love it because… 
…you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day. 

Profile...
•    Educated to honours degree level in a scientific field or equivalent experience
•    Multiple years Regulatory Experience and knowledge in NPD and dossier/technical file creation and US as well as other global registrations. 
•    Experience in different regulatory classifications such as cosmetics, medical devices, VMS (vitamins, minerals and supplements), food supplements, medicines and general products. 
•    Technical Competencies:
     1. Knowledge of the Regional and Global regulatory environment and how it impacts regulatory pathways, dossiers and registration
     2. Experience in preparing and submitting dossiers, variations and renewals.  
     3. Ability to communicate requirements
     4. Understanding of global product development practice, rules, regulations and guidelines.
     5. Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.  
     6. High level of accuracy in reviewing and authoring documentation
•    Knowledge of submission processes and product life cycle management activities for various consumer product categories.

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: Medical, Medical Device, Healthcare

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