Regulatory Affairs Associate - 12 Month Fixed Term Contract - GI
We are Reckitt
Research & Development
In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
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.
About the role
Reckitt is seeking a dedicated Regulatory Associate to join us in a 12-month fixed term contract, working on our GI portfolio, a role that sits at the core of our innovation process, ensuring that our new product developments meet global regulatory requirements with precision. You will act as a catalyst for change, using your detailed knowledge to create comprehensive dossiers crucial for product registrations. At Reckitt, every individual's contribution is key, and your role will be pivotal in navigating the intricate regulatory landscape to deliver products that enrich lives every day.
Your responsibilities
• Prepare, maintain and update local product registration and regulatory compliance records and databases.
• Ensure the regulatory compliance of ANZ products to bring competitive advantage to our brands.
• Amend registration dossiers as necessary for country-specific regulatory requirements, submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims.
• Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products.
• Assist with local statutory reporting requirements.
• Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues.
• Interface with government agencies and industry associations to assess the impact and implementation of required company compliance with all legislation and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products.
The experience we're looking for
- Experience in dossier creation, submission, and product lifecycle management.
- A track record of reviewing and authoring high-quality documents.
- Ability to deliver consistently under pressure, adhering to cost, time, and quality standards.
- Familiarity with the regulatory requirements for medical devices in the EU (MDR) and US (510k) would be beneficial.
- Commercially aware, adept at building partnerships and proposing improvements to enhance business processes.
- Capable of embracing change and setting clear objectives in line with our business goals.
The skills for success
What we offer
Equality
Job Segment:
Medical Device, Counseling, Nutrition, Gastroenterology, Healthcare