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Head of Regulatory Affairs Health - North European Region (UK/Ireland/ - Berkshire, Slough, SL1 0

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Job Title: Head of Regulatory Affairs Health - North European Region (UK/Ireland/Nordics)
Reports to: Director of Regulatory & Medical Affairs - Europe
Location: Slough, UK

No of Direct Reports: 5 - 7
Size of department (2014): ~30inc contractors, temps
Financial Responsibility (Direct):
• Relevant NE Health Administrative/Regulatory budget
• Determined annually aligned to UK/Ireland/Nordic needs


To deliver the regulatory and safety strategy for new products and ensure on-going compliance within the total UK/Ireland/Nordic region, leading to the growth of our North European Healthcare business.


• Direct all activities related to the implementation of regulatory and product safety strategies within the UK/Ireland/Nordic Region.
• Ensure on-going regulatory and product safety compliance of Reckitt Benckiser's UK/Ireland/Nordic existing product portfolio.
• Lead and co-ordinate the resolution of regulatory issues affecting UK/Ireland/Nordic products.
• Provide regulatory affairs leadership and support to internal and external customers within UK/Ireland/Nordic region
• Work closely with external partners, contractors and licensees to ensure that regulatory affairs issues are properly managed and resolved.
• Jointly with the European Regulatory Director and Global R&D Category Group Director - Regulatory Affairs define and execute the Company's regulatory strategy including implementation of local policies, guidelines and procedures.


Regulatory Affairs - All Products

• Ensure the registration and regulatory compliance of UK/Ireland/Nordic marketed healthcare products with relevant national and European regulatory requirements to bring competitive advantage to our brands.
• Documentation Management System:
• Ensuring the compilation of national dossiers for submissions to authorities
• Ensuring the preparation, maintenance and update of product registration/license and regulatory compliance files.
• Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals.
• Compiling Compliance Dossiers for manufacturing of products for the local markets
• Managing and maintaining regulatory documentation filing system.
• Developing national texts (e.g., PIL, SPC, packaging) including coordination of translations
• Regulatory Requirements:
• Work with key regulatory partners in the Global Regulatory Strategy, Operations and Compliance Teams to ensure key regulatory strategies are executed and ensure compliance of our healthcare portfolio.
• Developing and maintaining a database of local regulatory requirements within the UK/Ireland/Nordic region.
• Monitoring and interpreting UK/Ireland/Nordic regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant UK/Ireland/Nordic regulatory issues, and proactively leading the development and implementation of strategies to ensure regulatory compliance efforts that result in competitive advantage.

• Regulatory and Safety Advice
• Providing regulatory and product compliance expertise in the area of advertising, label claims and printed materials for existing and new products.
• Protecting key brand and product claims using medical and regulatory expertise.
• Providing technical support and advice to respond to consumer and legal inquiries, regulatory issues for our products marketed in UK/Ireland/Scanda.
• Providing advice to Legal and Finance in contract development, relating to medical and regulatory affairs and product safety.

Pharmacovigilance / Drug Safety Officer
• Lead a team that manages Vigilance activities for all drugs, devices and cosmetics within UK/Ireland/Nordic Region
• Drug Safety Management:
• Collecting, assessing and reporting of all adverse events and adverse drug reactions from the NE Region to Global Medical Affairs (Drug Safety) Group
• Fulfilling reporting requirements and timelines to authorities
• Record keeping on risk assessment and management
• Communicating with the Global Medical Affairs (Drug Safety) Group

• Drug Safety Training:
• Manage a team that conducts training of employees and contracted services in Pharmacovigilance requirements
• Ensuring that drug safety is a positive asset for the Company in marketing our products successfully, and training the Sales Force for corresponding alertness.
• Closely interacting with representatives of relevant UK/Ireland/Nordic government agencies, as required.

External Affairs
• Interfacing with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products.
• Representing Company interests with local government agencies, industry associations and/or other organizations for the purpose of negotiating legislation, regulations and/or guidelines that do not impose excessive or unfair burdens on our industry or products.
• Maintaining / establishing good relationships with key opinion leaders and customers. Informing key internal stakeholders on key opinion leaders and customers' expectations.


• People Development: Motivating and developing people within a results-oriented culture, where personal responsibility/ initiative, teamwork, and mutual respect are key
• Training: If necessary, preparation of training materials for internal training (e.g., for sales, marketing) and conducting training sessions on relevant scientific, regulatory and safety issues. Participating at and/or co-ordinating scientific symposia, congresses and round tables. Interacting with a network of opinion leaders will be required to assemble quality panels of speakers and references.
• Budget: Day to day management of the Regulatory budget.
• Active participation in the development and implementation of best practices across the regulatory and safety organisation

• Allocating resources across the project portfolio to achieve agreed project timelines.
• Facilitating the relationship with Category Development, Marketing, Supply and other functions to ensure the "seamless" building of healthcare regulatory affairs in our project and product portfolio.
• Managing the conflicting resource demands on NPD/EPD Development, cost saving initiatives and new technology projects.
• Ensuring the quality of regulatory and safety documentation for RB's North European products in an environment of continuous change.
• Working closely with the UK/Ireland/Nordic groups to ensure that Regulatory Strategies incorporated into Project Development Briefs are clear, concise and add value.
• Building an environment and culture which supports the core values and which enables people development.
• Continually building understanding of and insights into regulatory and safety compliance across the UK/Ireland/Nordic region.
• Developing and maintaining "leading edge" world class expertise in regulatory compliance within the UK/Ireland/Nordic Region.Link megjelenítése" width="0" height="0" />
Helyek Külföld
Kategória Külföldi munka
Aktiválás időpontja 2014.09.26.
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