Regulatory Affairs Associate

5 days ago

Sydney, New South Wales, Australia Reckitt Full time

We are Reckitt, home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

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
  1. Prepare, maintain and update local product registration and regulatory compliance records and databases.
  2. Ensure the regulatory compliance of ANZ products to bring competitive advantage to our brands.
  3. 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.
  4. Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products.
  5. Assist with local statutory reporting requirements.
  6. 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.
  7. 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
  1. Degree in a scientific field with a robust understanding of global regulatory environments impacting consumer products.
  2. Experience in dossier creation, submission, and product lifecycle management.
  3. A track record of reviewing and authoring high-quality documents.
  4. Ability to deliver consistently under pressure, adhering to cost, time, and quality standards.
  5. Familiarity with the regulatory requirements for medical devices in the EU (MDR) and US (510k) would be beneficial.
  6. Commercially aware, adept at building partnerships and proposing improvements to enhance business processes.
  7. Capable of embracing change and setting clear objectives in line with our business goals.
The skills for success

Commercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business Strategy.

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; 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.

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