Senior Regulatory Affairs Expert

2 days ago


Sydney, New South Wales, Australia beBeeregulator Full time $90,000 - $120,000
Job Description

We are seeking a highly skilled professional to manage the operational and technical aspects of regulatory affairs for our marketing affiliate.

The purpose of this role is to execute the regulatory plan to ensure the success of new product registration, line extensions and new indications in alignment with the business plan, while maintaining compliance for all products with local regulations and quality system requirements.

Responsibilities
  • Regulatory Plan Execution: Execute the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the business plan, while maintaining compliance for all products with local regulations and quality system requirements.
  • Regulatory Compliance: Foster an environment of operational excellence and collaborate with cross-functional teams to successfully achieve Affiliate regulatory objectives.
  • Labelling: Facilitate and cultivate relationships with the local regulatory agency/MoH.
  • Process Improvement:
  • Personal and Professional Development:
Benefits

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We foster an inclusive environment where everyone can thrive.

We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Requirements
  • Mid-Senior level experience in Regulatory Affairs
  • Full-time employment
  • Legal job function
  • Pharmaceutical Manufacturing industry

Location: Sydney, New South Wales, Australia



  • Sydney, New South Wales, Australia beBeeregulatory Full time $115,000 - $125,000

    Regulatory Affairs Expert | Rare Disease SpecialistThe role of Regulatory Affairs Expert is pivotal in the development, approval, and lifecycle management of innovative medicines. This global position offers a unique opportunity to take full ownership of regulatory affairs across ANZ.Develop and execute strategic regulatory submission plans to support new...


  • Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Regulatory Affairs LeadAbout the Position:The Regulatory Affairs Lead plays a critical role in driving key regulatory activities, ensuring compliance with relevant regulations and legislation. This individual will bridge strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and...


  • Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Senior Specialist Regulatory AffairsThis is a highly skilled and experienced Senior Specialist Regulatory Affairs role in Sydney, Australia. The successful candidate will have significant expertise in regulatory affairs within the medical devices industry, with a proven track record of leading global regulatory submissions.Key Responsibilities:Author and...


  • Sydney, New South Wales, Australia beBeeRegulatory Full time $135,000 - $155,000

    Job Title: Regulatory Affairs ExpertJob Description:We are seeking a highly skilled Regulatory Affairs professional to join our team on a short-term, part-time basis during a critical period.As a Regulatory Affairs expert in the post-market regulatory field, you will work across various activities to ensure compliance for our marketed medical devices.The...


  • Sydney, New South Wales, Australia beBeeRegulatory Full time $138,000 - $188,500

    Regulatory Affairs SpecialistJob OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to lead our global regulatory strategy and submission execution for physical products manufactured by our company. As a key member of the team, you will play a critical role in shaping the future of our business.Main Responsibilities:Develop and execute...


  • Sydney, New South Wales, Australia Heng & Hurst Full time

    Regulatory Affairs Manager | Rare Disease | SYDJoin to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & Hurst Regulatory Affairs Manager | Rare Disease | SYD1 day ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & Hurst Get AI-powered advice on this job and...


  • Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000

    Job DescriptionThe Regulatory Affairs team plays a crucial role in shaping regulatory strategy and submission execution for physical products. As a Senior Specialist, you will lead submission planning and execution, influencing design documentation and contributing to regulatory strategy.You will collaborate across functions to drive global submission...


  • Sydney, New South Wales, Australia beBeeDiversity Full time $80,000 - $120,000

    Regulatory Affairs ExpertWe are seeking a highly skilled Regulatory Affairs professional to join our team. As an Advisor, you will lead engagement across APRA to ensure our external regulatory relationships are supported by relevant subject matter expertise.The successful candidate will work on a broad range of diverse issues that are important to...


  • Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000

    Senior Specialist Regulatory Affairs Job DescriptionAbout the RoleThe Senior Specialist Regulatory Affairs will be responsible for leading regulatory strategy and execution for ResMed's core portfolio of devices. This includes authoring and reviewing global regulatory submissions, interpreting device-specific requirements, and aligning closely with Regional...


  • Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $100,000 - $155,000

    Regulatory Affairs Leadership RoleThis role requires a skilled and experienced professional to lead regulatory affairs initiatives, driving business growth and ensuring compliance with local regulations.Key Responsibilities:The Senior Regulatory Affairs Associate will be responsible for:Developing and implementing regulatory strategies to support product...