Regulatory Affairs Associate - 12 Month Fixed Term Contract - GI at Reckitt
Sydney NSW 2000, New South Wales, Australia -
Full Time


Start Date

Immediate

Expiry Date

26 Jun, 25

Salary

0.0

Posted On

27 Mar, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Partnership Building, Medical Devices, Partnerships, Business Strategy, Mdr, Regulatory Requirements, Accountability, Consumer Products, Product Lifecycle Management, Commercial Awareness, Collaboration

Industry

Pharmaceuticals

Description

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.

THE EXPERIENCE WE’RE LOOKING FOR

  • Degree in a scientific field with a robust understanding of global regulatory environments impacting consumer products.
  • 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

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.

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

Responsibilities

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.
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