Regulatory Affairs Associate

2 weeks ago

Sydney, Australia Lula Group Full time

Hybrid working model
- Highly-known company across APAC
- Long term career progression

**About the Company**

Our client, a renowned Pharmaceutical company with a strong presence across the APAC region, is in the process of expanding its headquarters in Sydney. They are currently looking to add a skilled Regulatory Affairs Associate to their growing team. This company is highly recognised across nutrition, beauty, health, and household products.

**About their Team**
A tightly-knit group of 50 individuals who are aligned in their objectives, successfully reaching milestones both independently and as a collective. Diversity of perspectives is highly valued within this team, fostering an environment where innovation is encouraged and your individual strengths are not only acknowledged but celebrated.

**The Opportunity**
You will be responsible for various regulatory activities which include preparing submissions for Australian regulatory authorities and maintaining communication with them. Additionally, involvement in strategic aspects of submissions, like establishing timelines and submission methods, will be required. This role will also entail the responsibility of creating and drafting essential documents as needed.

**Your responsibilities & duties**
- Undertake market research to stay ahead of competitors
- Work closely with stakeholders to ensure oversight of all regulatory matters
- Work within the Regulatory & Governance function
- Communicate with stakeholders to support the preparation of regulatory submissions
- Provide regulatory support for BUs as required

**Your skills & experience**
- Previous experience working with a Pharmaceutical company is beneficial
- Strong technical writing skills
- Knowledge of GMP, CMC and local guidelines is highly beneficial
- Strong attention to detail
- Background working across APAC & NZ is beneficial

**Their benefits to you**:

- Full-time opportunity - growing and stable company
- Room for career progression - salary reviews
- Ongoing training and development to grow your skillset
- Full-time opportunity

**How to apply

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