Regulatory Affairs Director for Pharmaceutical Success

4 weeks ago


Sydney, New South Wales, Australia PharmaLex GmbH Full time

We are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia.

About Us

Pharmalex is a leading service company for the Pharmaceutical Industry globally, specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.

Your Job

In this role, you will work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors, to ensure appropriate licensing, marketing, and regulatory compliance of client products.

You will advise, support, and manage regulatory submissions and approvals for products, including liaising with clients, regulatory teams, and third-party subject matter experts.

Your Profile
  • A minimum of 10 years' experience working in regulatory affairs for prescription products in industry or a consulting setting
  • Formal qualifications in science or a similar field
  • Recognized as a technical expert within the Australian regulatory environment
  • Extensive experience in prescription medicines Regulatory Affairs within Australia and New Zealand
  • Leadership roles demonstrating ability to achieve results through people and develop a positive team culture
Benefits

By joining the PharmaLex GmbH team, you will become part of a team renowned as specialists in our field. You will work closely with experienced Senior Managers, Associate Directors, and Directors who have extensive consulting experience.

We offer a range of flexible working options, including varying start and finish times, hybrid working, and opportunities to build new skills and capabilities and grow your career.

Our head office is based in St Leonard's, Sydney, NSW, Australia. Ideally, candidates will be Sydney-based; however, Melbourne, Canberra, or Brisbane locations may be considered.

We estimate the salary for this role to be approximately AU$180,000 - AU$250,000 per year, depending on experience.



  • Sydney, New South Wales, Australia PharmaLex Full time

    OverviewWe are seeking a highly experienced Regulatory Affairs Director to join our Pharmaceutical Consulting team in Australia.This is an exceptional opportunity to lead a team of skilled Regulatory Consultants and work with a diverse range of clients, primarily in the pharmaceutical and healthcare sectors.Your primary objective will be to maximize client...


  • Sydney, New South Wales, Australia PharmaLex Full time

    About the Opportunity We are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. This role will involve working with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective will be to maximize client commercial success by ensuring appropriate...


  • Sydney, New South Wales, Australia PharmaLex Full time

    We are seeking a highly experienced Regulatory Professional to lead our team in Australia.Company OverviewPharmaLex is a renowned specialist in the field of pharmaceutical regulatory consulting. Our team of experts provides high-quality services to clients across various industries.About the RoleThis role offers an exciting opportunity to work with a broad...


  • Sydney, New South Wales, Australia PharmaLex Full time

    Job OverviewWe are seeking an experienced Regulatory Professional to join our team in Australia. The successful candidate will have the opportunity to work with a range of clients, predominantly in the pharmaceutical and healthcare sectors.Key Responsibilities:Maximize client commercial success by ensuring licensing, marketing, and regulatory compliance of...


  • Sydney, New South Wales, Australia Ambition Full time

    Ambition is a leading pharmaceutical company specializing in OTC healthcare products, seeking an experienced Quality Assurance Director to lead our quality assurance and regulatory affairs.The Role:Lead a team of four professionals focused on quality assurance, regulatory affairs, and technical aspects of product development.Ensure all products meet required...


  • Sydney, New South Wales, Australia PharmaLex Full time

    Overview">We are seeking a seasoned Regulatory Affairs professional to join our team as a Senior Consultant in Australia. The successful candidate will have extensive experience working with pharmaceutical and healthcare clients, ensuring compliance with regulatory requirements and maximizing commercial success.">About the Role">This role involves leading...


  • Sydney, New South Wales, Australia Colgate-Palmolive Company Full time

    About the Role:We are seeking a Regulatory Affairs Associate to join our team at Colgate-Palmolive Company. As a key member of our Regulatory Affairs function, you will be responsible for delivering efficient and effective regulatory strategy solutions to support the optimal business outcomes for our South Pacific subsidiaries.Key Responsibilities: ...


  • Sydney, New South Wales, Australia Johnson & Johnson Full time

    Company OverviewJanssen, a pharmaceutical company dedicated to developing life-changing treatments, is seeking a skilled Senior Regulatory Affairs Associate to join its team. With a focus on product innovation and customer satisfaction, Janssen strives to deliver exceptional outcomes for patients and customers.Salary: $120,000 - $160,000 per annum, based on...


  • Sydney, New South Wales, Australia Careerlink People Solutions Full time

    Careerlink People Solutions is partnering with BiomeBank to present a unique opportunity for an experienced professional in regulatory affairs to join the team as Regulatory Affairs Strategist.BiomeBank, a clinical stage biotechnology company, aims to treat and prevent disease by restoring gut microbial ecology. With a mission-driven approach, they have...


  • Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    Regulatory Affairs Role at Stryker Australia Pty LtdWe are seeking a highly experienced Senior Regulatory Affairs Specialist to join our team in Melbourne, Australia. This is an exciting opportunity for a talented professional to work with a leading global medical device company.The successful candidate will have a minimum of 5 years' experience in...


  • Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Strategist to join our high-performing regulatory team at Stryker Australia Pty Ltd.Job DescriptionThis senior role will focus on preparing and submitting device registration applications, including complex submissions such as Class III and/or TGA Conformity Assessment applications. You will...


  • Sydney, New South Wales, Australia Johnson & Johnson Full time

    Regulatory Affairs Specialist Position OverviewJohnson & Johnson is currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in supporting our business growth by providing regulatory leadership of a portfolio of products.Main Responsibilities:Lead a...


  • Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of our Regulatory Affairs team, you will be responsible for leading the development and implementation of regulatory strategies for a portfolio of products.You will work closely with cross-functional teams to ensure that regulatory submissions...


  • Sydney, New South Wales, Australia ResMed Full time

    At ResMed, we are shaping the future of medical technology with a global team of over 7,500 talented individuals. As a Regulatory Affairs Student Engineer, you will play a crucial role in providing support and guidance on regulatory matters across our product life cycle.The RA Systems and Business Excellence team is dedicated to establishing efficient tools,...


  • Sydney, New South Wales, Australia On Q Recruitment Full time

    About On Q RecruitmentOn Q Recruitment is proud to partner with an ASX-listed medical device company in their search for a Senior Manager – Global Regulatory Affairs & Quality Assurance.Job OverviewThis is a permanent, full-time position that offers excellent work-from-home flexibility. As a key member of the leadership team, you will play a pivotal role...


  • Sydney, New South Wales, Australia Johnson & Johnson Full time

    Company OverviewJanssen, a part of Johnson & Johnson, is a global healthcare leader driven by a dedication to innovation and customer focus.Job SummaryWe are seeking an experienced Regulatory Affairs Project Manager or Senior Regulatory Affairs Associate to join our team in North Ryde (open to other states). As a key member of the Regulatory Affairs team,...


  • Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    We are seeking an experienced Regulatory Affairs Professional to join our team at Stryker Australia Pty Ltd.The ideal candidate will have a minimum of 5 years' experience in Regulatory Affairs, with expertise in Class III and TGA conformity assessment applications.This role is perfect for someone who is passionate about medical devices and regulatory...


  • Sydney, New South Wales, Australia PharmaLex Full time

    At PharmaLex, we are seeking an experienced Regulatory Affairs Professional to join our team in Australia.Job OverviewThis is a leadership role that requires a strong track record of regulatory work spanning the entire product lifecycle. You will lead a team of highly skilled Regulatory Consultants and be responsible for maximizing client commercial success...


  • Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full time

    At Device Technologies Australia Pty Ltd, we are driven by a vision to improve patients' lives through innovative medical solutions.We are seeking a highly skilled Regulatory Affairs Associate to join our team in Sydney. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local requirements and regulations for...


  • Sydney, New South Wales, Australia ResMed Full time

    ResMed is committed to shaping the future of healthcare by creating innovative medical technology solutions. Our company overview highlights our focus on improving millions of lives, fostering a diverse and inclusive culture, and promoting individual expression in the workplace.Estimated SalaryAverage salary for this role in Sydney ranges from AU$60,000 to...