Director of Regulatory Affairs

7 days ago


Sydney, New South Wales, Australia PharmaLex GmbH Full time

Company Overview

PharmaLex GmbH is a leading service company for the pharmaceutical industry globally, specialized in all aspects of drug and medical device approval, market development, and effective product maintenance.

Job Description

We have an opportunity for an experienced regulatory professional to join our pharmaceutical regulatory consulting team. In this role, you will work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective is to maximize client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of products.

Required Skills and Qualifications

  • You have formal qualifications in science or a similar field and a minimum of 10 years' experience working in regulatory affairs, either for prescription products in industry or a consulting setting.
  • You are recognized as a technical expert within the Australian regulatory environment, with a strong track record of regulatory work spanning the entire product lifecycle.
  • You have worked in leadership roles, demonstrating the ability to achieve results through people and develop a positive team culture.
  • You are a natural problem-solver, critical thinker, commercially minded, and have exceptional communication skills and stakeholder management skills.


  • Sydney, New South Wales, Australia QBE Insurance Group Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic direction and guidance on regulatory compliance matters across the organization.**Key Responsibilities:**Provide input and strategic direction into the organization's...


  • Sydney, New South Wales, Australia PharmaLex GmbH Full time

    We are growing, grow with usAre you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, market development, and effective product...


  • Sydney, New South Wales, Australia Stryker Group Full time

    We are seeking a seasoned Regulatory Affairs professional to fill the role of Senior Regulatory Affairs Associate at Stryker. As a member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and contributing to business growth.Primary ResponsibilitiesOversee the preparation and submission of device registration...


  • Sydney, New South Wales, Australia PharmaLex GmbH Full time

    A technical expert within the Australian regulatory environment is sought after to lead our Pharmaceutical Regulatory Consulting team in Australia. In this role, you will work on regulatory assessments for early pipeline products and new technologies, maximizing commercial success through strategic regulatory advice.This leadership position requires a...


  • Sydney, New South Wales, Australia Osseointegration International Full time

    At Osseointegration International, we're pushing the boundaries of orthopaedic care. As a Regulatory Affairs Associate, you'll be part of a multidisciplinary team dedicated to providing optimum patient outcomes.We're looking for an individual with a solid track record in regulatory affairs, particularly in orthopaedic medical devices. Your expertise will...


  • Sydney, New South Wales, Australia Osseointegration International Full time

    Company DescriptionOsseointegration International is a global orthopaedic provider based in Sydney, NSW. The company provides optimum care by a multidisciplinary team of experts and a long-term clinical follow-up program to assist patients in every step of their journey and performed over 1500 surgeries globally. The organization partners with leading...


  • Sydney, New South Wales, Australia Stryker Group Full time

    Stryker is seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team. This role offers the opportunity to work with a leading global medical device company that prioritizes patient outcomes and excellence.About the RolePrepare and submit device registration applications, including complex submissions such as...


  • Sydney, New South Wales, Australia Osseointegration International Full time

    Direct message the job poster from Osseointegration InternationalDriving Innovations in Orthopedic Medical DevicesCompany DescriptionOsseointegration International is a global orthopaedic provider based in Sydney, NSW. The company provides optimum care by a multidisciplinary team of experts and a long-term clinical follow-up program to assist patients in...


  • Sydney, New South Wales, Australia QBE Insurance Group Full time

    QBE Insurance Group is committed to providing exceptional service to our customers by staying ahead of the curve in terms of regulatory compliance. As an Insurance Regulatory Affairs professional, you will play a key role in ensuring our organisation remains compliant with all relevant regulatory requirements.About the RoleStaying up-to-date with changes to...


  • Sydney, New South Wales, Australia Paxus - Technology + Digital Talent Full time

    The Paxus - Technology + Digital Talent team is looking for an experienced Regulatory Affairs Assistant to join their Regulatory Affairs team. As a key contributor, this role will provide administrative support, maintain accurate records and information systems, and respond to enquiries in a timely and professional manner.Key Responsibilities:Maintain...


  • Sydney, New South Wales, Australia Genea Biomedx Full time

    We are seeking a Regulatory Affairs Specialist to join our team in Sydney, Australia. This role is responsible for ensuring regulatory compliance of medical devices with the Therapeutic Goods Administration (TGA) and other relevant global regulatory bodies. The ideal candidate will have strong knowledge of regulatory requirements, product registration...


  • Sydney, New South Wales, Australia Osseointegration International Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Osseointegration International. The successful candidate will be responsible for managing and coordinating regulatory documentation, ensuring compliance with international standards and laws, determining regulatory requirements for product registrations, and...


  • Sydney, New South Wales, Australia QBE Europe Full time

    We are looking for a Regulatory Affairs Lead to join our team at QBE Europe. As a key member of our Regulatory Affairs team, you will collaborate with the Head of Regulatory to enhance and drive our Regulatory Change Management Framework for regulatory change and AUSPAC's Regulatory Engagement Policy for managing relationships with conduct regulators.Job...


  • Sydney, New South Wales, Australia Colgate Full time

    We are a leading consumer products company serving hundreds of millions of consumers worldwide.We operate in four core businesses – Oral Care, Personal Care, Home Care, and Pet Nutrition.Job Title: Regulatory Affairs AssociateThe Regulatory Affairs Associate will be responsible for delivering regulatory strategy solutions to support the business.Main...


  • Sydney, New South Wales, Australia Colgate Full time

    At Colgate-Palmolive, we are committed to delivering high-quality products that make lives healthier and more enjoyable.Job Title: Regulatory Affairs AssociateThe Regulatory Affairs Associate is responsible for developing and implementing efficient regulatory strategies to ensure compliance with Australian and New Zealand regulations.Main...


  • Sydney, New South Wales, Australia Osseointegration International Full time

    Job ResponsibilitiesThe Regulatory Affairs Associate will be responsible for managing and coordinating regulatory documentation, ensuring regulatory compliance with international standards and laws, determining regulatory requirements for product registrations, and leading regulatory submissions.This role requires a high level of expertise in regulatory...


  • Sydney, New South Wales, Australia Reckitt Benckiser LLC Full time

    About the Role: We are seeking a skilled Regulatory Affairs Associate to join our team in a 12-month fixed term contract. As a key member of our GI portfolio, you will play a pivotal role in ensuring that our new product developments meet global regulatory requirements with precision.


  • Sydney, New South Wales, Australia Colgate Full time

    Established in 1806, Colgate-Palmolive is a truly global consumer products company with a rich history and legacy of innovation.We serve hundreds of millions of consumers worldwide with brands and products across four core businesses – Oral Care, Personal Care, Home Care, and Pet Nutrition.A career at Colgate-Palmolive offers a unique opportunity to make a...


  • Sydney, New South Wales, Australia Rabobank Gruppe Full time

    Rabobank is the world's leading specialist in food & agribusiness banking.One of our key strengths lies in our people who have a deep understanding of agriculture & are committed to adding long-term value for clients.Our commitment to our employees & clients is at the heart of everything we do.The role: Rabobank has an opening for Regulatory Affairs...


  • Sydney, New South Wales, Australia NXTGIG Full time

    Compliance Role in Financial ServicesWe are looking for an experienced Regulatory Affairs Officer to oversee our organization's compliance with APRA and ASIC regulations. As a key member of our compliance team, you will play a vital role in ensuring our business operations align with regulatory requirements. Your responsibilities will include conducting...