RA Manager
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
Provide the regulatory and safety support for Reckitt products (assigned categories: OTC, VMS, Med Devices) and ensure on-going compliance, leading to the growth of business in Taiwan.
Your responsibilities
•Ensure the registration and regulatory compliance of Reckitt’s marketed products with relevant national regulatory requirements to bring competitive advantage to our brands.
•Documentation Management System:
•Compilation of registration dossiers for submissions to authorities
•Preparation, maintenance and update of product registration/license and regulatory compliance files.
•Amend the 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.
•Management of Pharmacovigilance activities for all drugs are carried out within Taiwan
•Drug Safety Management:
•Collecting, assessing and reporting of all adverse events and adverse drug reactions to Global Medical Affairs (Drug Safety) Group
•Monitoring medical and regulatory publications and intelligence reports for changes in international regulations governing safety reporting, class labelling for relevant products, etc.
•Support the Country RAS Head in the 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.
•Maintaining / establishing good relationships with key opinion leaders and customers. Informing key internal stakeholders on key opinion leaders and customers’ expectations
The experience we're looking for
•Results oriented, entrepreneurial and self-motivating
•Strong leadership, motivational and interpersonal skills
•Commercial understanding of corporate and operational business issues
•Strong understanding of marketing strategy, planning issues, budgeting, priority setting, project management
•Ability to transform solid thinking into action (a thinker and an achiever)
•Excellent communication skills both written and oral (in English)
•Strong intellectual curiosity
•Appetite for exploring new and previously uncharted territories
•Openness to change and ability to think out of the box
•Excellent Presentation skills
The skills for success
What we offer
Equality
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