Regulatory Affairs Assistant

3 months ago

Macquarie Park, Australia MSD Full time

**Regulatory Affairs Assistant**
- ** Full-time permanent** role with competitive renumeration 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 Oncology portfolio and pipeline**

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Regulatory Affairs role is of critical importance, requiring successful execution of strategic partnerships with: Regulatory Agencies, Regulatory Affairs International, and internal company groups, using effective communication whilst maintaining ethical work practices.

**What You Will Do**

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

- With supervision, review, compile and submit basic registration dossiers and data packages, within timeframes agreed with manager and in accordance with government, industry and corporate requirements to maintain regulatory compliance and facilitate product supply.
- Manage assigned tasks and time effectively, and ensure compliance to global and local policies, and effective and timely communication of new or amended registered details to stakeholders within the company.

**Regulatory and Technical Support**
- With support, provide regulatory and technical advice to other parts of the organization on basic issues to ensure that correct and compliant information is used in decision making and strategy development.

**Develop and Maintain Key Relationships**
- Actively collect, with support, analyse and disseminate regulatory intelligence and other information in accordance with commercial interests.
- Effectively participate in Regulatory team discussions, bringing forward issues for consideration and contributing to the development of solutions and strategies.
- Foster professional relationships with individuals within TGA and Medsafe who would be responsible for evaluating our own company’s submissions.

**Mentoring and Team Work**
- Effectively participate in RA Team joint projects or Department projects
- Assist with training other Regulatory Affairs team members when applicable.
- Help with other team functions as required.

**What You Must Have**
- Must have a pharmacy degree or life sciences degree
- Australian Regulatory Affairs experience in Prescription Medicine, preferred

**What You Can Expect**
- Support and progression within an established team who are well regarded by the company
- Opportunity to develop, grow and encouraged to succeed, in a diverse Regulatory Affairs position

**Who we are **

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for** Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R240994

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