Regulatory Affairs Specialist

7 months ago

Macquarie Park, Australia MSD Full time

**Regulatory Affairs Specialist**
- ** Looking for a different challenge as a Regulatory Affairs Specialist **whereby you can still utilise your skills?
- ** Permanent Full-time **position with **competitive renumeration **and** benefits**
- Ideally based from **Sydney Australia**, also open to **NZ** located applicants
- Hybrid, work from home and office environment, with a **dedicated and welcoming team**
- Join a growing, yet already **successful market**
- ** Upskill and growth in an area you’re passionate about**, whilst being fully supported and encouraged.
- Join **a **Trusted Global Leading** Animal Health **organisation

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 company'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**

**Responsibilities include, however not limited to**:

- 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 our company’s Animal Health's 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**:
**_ Education and Experience:_**
- Graduate or Post-Graduate degree in a relevant biological science field
- Solid amount of experience in a related industry
- Experience in the animal health industry or pharmaceutical manufacturing is highly beneficial

**_ Regulatory Knowledge_**
- Familiarity with the Australian and New Zealand Regulatory Systems (e.g., APVMA, DAFF, ACVM).

**_ Leadership and Communication_**
- Strong negotiation and influencing skills.
- Excellent communication (both written and verbal) and organizational skills.
- Ability to work collaboratively in a team setting.

**_ Analytical and Problem-Solving Skills_**
- 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 Global Leading Animal Health organisation
- Exposure to **upskill and develop** in your role
- Flexibility and **opening doors to other opportunities** and skillsets
- Joining 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)**:
**Requisition ID**:R282210

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