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Regulatory Affairs Associate Manager, Compliance

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Kingston, Großbritannien
Lagerhaltung/Logistik, Englisch
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Beschreibung:

RB is different: 'good enough' isn't good enough here.

RB is the world's leading consumer health and hygiene company, We work with the best people to challenge conventional thinking and keep giving people innovative solutions for healthier lives and happier homes, through our brands like Nurofen, Strepsils, Mucinex, Dettol, Lysol, Finish and Vanish

Ihr Profil:

A fantastic opportunity for an experienced Regulatory Affairs Associate Manager (Compliance) to join a successful team, based in Hull

We're proud of our organisation and continually strive to be the best that we can be. The Associate Manager role plays an essential role in leading maintenance and compliance activities within the existing portfolio of products.
As an Associate Manager you will lead a team of regulatory professionals, taking direct responsibility for the line and performance management pf those individuals and ensure that all required registration and regulatory activities are completed in the appropriate and agreed timeframes to protect our existing business.
You will be responsible for leading and executing the successful delivery of post approval/post launch maintenance activities and projects in line with the approach agreed and in compliance with the departmental Standard Operating Procedures.
You will work in close collaboration with partner functions and regional Regulatory colleagues to share regulatory advice and guidance to the business during these post approval/post launch activities for a defined portfolio of products.

Key responsibilities will include:

· be responsible for the efficient and effective execution and project management of post approval maintenance regulatory activities, (e.g. renewals, variation or general update of regulatory documentation), at a high level of quality and accuracy, to ensure successful delivery of assigned projects activities within agreed timelines.
· work in partnership and support as required other regulatory functions in developing, reviewing and/or executing regulatory activities or internal guidelines to ensure regulatory requirements are taken into account and strengthen the efficiency and quality of the deliveries of the regulatory function globally.
· project manage and work closely with the regional and local teams to develop a schedule for routine product maintenance
· maintain and develop knowledge and intelligence across the Regulatory Function to ensure accurate maintenance of existing products in all markets
· develop and propose regulatory success path to your line manager, ensuring appropriate and relevant legislative and technical elements are identified and incorporated utilising regulatory intelligence and experience
· utilise his/her understanding of stakeholders as well as product expertise to deliver excellent regulatory support and maintain the base of our business healthy.
· develop good working relationships with peers and external contacts to become a recognised business partner, proactively guiding them through existing regulatory requirements and raising awareness of upcoming changes to legislation and regulatory environment directly affecting our daily business
· use regulatory expertise to assess the impact of changes proposed by business partner or by new regulation, identify and communicate related risk and feeds into action plans to manage them efficiently.
· deputise, as appropriate, for the Regulatory Manager and support project management and delivery of your direct reports.
· drive your personal development and that of his/her team, to ensure outperformance. Ensure regulatory knowledge is maintained and contributes to RB regulatory intelligence.

Is this you?

* Educated to honours degree level in a scientific field or equivalent experience
* Experienced in developing Global Regulatory strategies
* Relevant Regulatory experience and knowledge in dossier / technical file creation and global registrations.
* Experience in a range of classifications of Healthcare products - ideally medical devices, cosmetic and medicines
* Knowledge of the Regional and Global regulatory environment 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
* Experience of line management

If you want to be part of creating something really different and think you have what it takes to succeed at RB, you should consider joining our team.

Apply Now for a chance to really change the game

Quelle: Website des Unternehmens
Datum: 05 Jul 2019
Dauer: 0 Monate
Sprachkenntnisse: Englisch
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