Regulatory Affairs Specialist

1 day ago

Macquarie Park, Australia MSD Full time

**Regulatory** Affairs Specialist**
- Permanent Full-time Opportunity based in Sydney
- Join a market leading, experienced and motivated team in a growing exciting market

The Regulatory Affairs Specialist plays a crucial role in ensuring internal and external regulatory compliance for the manufacture, importation, and supply of the entire animal health product range in Australia and New Zealand. The pharmaceutical industry in Australia and New Zealand is highly regulated and competitive, making it essential for the compashny's success to navigate regulatory processes efficiently and effectively.

The Regulatory Affairs Specialist sits within the Regulatory Affairs Operations organization and reports to Regulatory Affairs Operations Team Leader.

**What You Will Do**
- Compliance Management: Taking ownership of regulatory processes is another key responsibility. This includes managing changes in artwork, approving marketing materials, ensuring regulatory reporting and maintenance of permits and licenses, and adhering to internal policies and legislative requirements.
- Change Control Support: The Specialist provides regulatory input for change control processes across manufacturing and quality network. This involves contributing to decision making and strategy development by offering regulatory and technical advice to other parts of the organization.
- Pharmacovigilance Support (if applicable): If the Specialist has pharmacovigilance responsibilities, they must maintain current pharmacovigilance training and assist in processing local pharmacovigilance cases in compliance with company and regulatory requirements.

**What You Must have**
- Graduate or Post-Graduate degree in a relevant biological science field.
- Minimum 5 years of experience in a related industry.
- Experience in the animal health industry or pharmaceutical manufacturing is highly beneficial.
Familiarity with the Australian and New Zealand Regulatory Systems (e.g., APVMA, DAFF, ACVM).
Strong negotiation and influencing skills.
- Excellent communication (both written and verbal) and organizational skills.
- Ability to work collaboratively in a team setting.
- Ability to analyse data with a logical and analytical approach to problem-solving.
- Demonstrated ability to work across diverse projects and stakeholders.

**What You Can Expect**
- Work autonomously whilst being supported, encouraged and being part of a trusted, leading Global Animal Health organisation
- Exposure to upskill and develop in your role
- Join a collaborative team of likeminded individuals

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
06/3/2025

**Requisition ID**:R346819

  • Regulatory Affairs Assistant

    5 days ago

    Macquarie Park, Australia MSD Full time

    **Regulatory Affairs Assistant** - Permanent full-time role with competitive remuneration and benefits - Opportunity to work within a highly respected, top tier, global pharmaceutical company - Be part of an established, capable, supportive and highly regarded team - As a Regulatory Affairs Assistant you will have diverse role responsibly for an integral...

  • Regulatory Affair Associate

    1 week ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    **About Aegros** Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access. At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In...

  • Regulatory Affairs Specialist

    6 days ago

    Macquarie Park, New South Wales, Australia EMVision Medical Devices Full time $90,000 - $120,000 per year

    Winner of the AFR 2023 Most Innovative Companies Award in Healthcare.Medical device industry, based in Macquarie Park.Opportunity to join a progressive and well-funded start-up Company.Work on 'world first' products set to transform stroke and traumatic brain injury care.Join EMVision and be a part of a company developing and commercialising innovative...

  • Regulatory Affairs Manager, Australia Animal Health

    3 days ago

    Macquarie Park, Australia MSD Full time

    **Regulatory Affairs Manager | Animal Health** - **Permanent Full-time **position with **competitive renumeration **and** benefits** - ** Based: AUS - New South Wales - Macquarie Park** - Join a growing, yet already **successful business** - **Upskill and growth in an area your passionate about**, whilst being fully supported and encouraged. - Join a...

  • Corporate Affairs Lead

    7 days ago

    Macquarie Park, Australia AstraZeneca Full time

    **About AstraZeneca** At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognising their potential. Relationships & engagement with government bodies,...

  • Consumer Affairs Lead

    1 day ago

    Macquarie Park, New South Wales, Australia Wilkinson Sword LTD Full time $104,000 - $160,000 per year

    DescriptionLet's Talk About YouYou're ambitious, but you want a career with purpose—we love that. You're up for a challenge and ready to write the next chapter of your career story with a great group of encouraging colleagues. You want to make your mark and let your personality shine.We are looking for an experienced Professional on fixed term contract to...

  • Associate Regulatory Specialist

    5 days ago

    Macquarie Park, Australia Ecolab Full time

    **About ECOLAB**: Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier - protecting people and vital resources. A trusted partner at nearly three million customer locations, Ecolab is the global leader in water, hygiene and energy technologies and services that...

  • Clinical Affairs Associate

    6 days ago

    Macquarie Park, New South Wales, Australia EMVision Medical Devices Limited Full time $80,000 - $120,000 per year

    Winner of the AFR 2023 Most Innovative Companies Award in Healthcare.Medical device industry, based in Macquarie Park.Opportunity to join a progressive and well-funded start-up Company.Work on 'world first' products set to transform stroke and traumatic brain injury care.Join EMVision and be a part of a company developing and commercialising innovative...

  • Sales & Marketing Associate - Medical Device

    7 days ago

    Macquarie Park, Australia Austcorp Executive Full time

    Are you a customer service professional with a scientific qualification? - Do you thrive in an environment where you are given responsibility? - Are you looking to expand your knowledge in a technical field? **About the Business** Our client is an international leader in the field of optics. They offer market leading products in the Optics and Medical...

  • Ict Security Specialist

    2 weeks ago

    Macquarie Park, Australia Tech Mahindra Full time

    **Designation / Job title**: ICT Security Specialist - 262112 **Primary or Mandatory skills: - ** Project Management Security specialist **Good to have skills**: IDAM experience Cyber Security knowledge Information security understanding **Detailed Job description : -** - Cyber Security & GRC Platform which seeks to modernise and simplify enterprises...