Scientific And Regulatory Associate

Flexible wroking solutions
- Stable Global CRO
- Join a company where you are recongnised and considered

**Who are we?**
We're Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980's. If you already work in this industry you'll know that we are experts in our field.

**Why should you join Avance Clinical?**
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

**Core Responsibilities**
- Support IP management and logistics activities including but not limited to:

- IP label development and review
- IP shipping document preparation and review
- IP import/export permit preparation
- Liaison with Sponsor, Avance Clinical, third-party vendor, and site staff to
facilitate timely management of IP preparation, packaging, labelling,
distribution, and returns (as applicable)
- Assist in the preparation of pharmacy manuals and other relevant documents requiring investigational product expertise.
- Develop an extensive and up-to-date knowledge of Australian and

international pharmacy, scientific and regulatory guidelines and GXPs (e.g.,
ICH E3, E6 (GCP), E8, E9 and E14, and PIC/S GMP).
- Develop familiarity with regulations and requirements relating to logistics and

management of investigational medicinal products and investigational devices
to enable the provision of advice to and/or resolution of inquiries/requests
from prospective and existing clients, as appropriate.

**Departmental Responsibilities**
- Actively contribute towards the ongoing development and growth of the

scientific, regulatory, and medical consultancy business to support clients
with their drug development programs and regulatory requirements, which
may also include timeline projections, support with investigational product
logistics and other vendor selections.
- Contribute to the development, creation and/or review of company

documentation (including Standard Operating Procedures, Manuals, Study
Plans, and forms/templates) to ensure compliance with regulatory
requirements.
- Assist the VPGSRA in finance reporting for the Scientific and Regulatory

Affairs Department
- Participate in both internal and external audits as required.

**Qualifications, Skills and Experience**
- B. Pharm (highly desirable), M.Sc. or Ph.D. in a scientific discipline or related

field, or ordinary degree in Life sciences with appropriate industry
experience.
- Minimum 2 years' experience in the biotech/pharmaceutical/CRO/life science

industry, including prior experience with clinical Research & Development.
- Understanding of applicable Australian and international Regulations, Acts

and Guidance Documents relating to investigational products and clinical
trials.
- Previous experience with logistics and management of investigational

medicinal products or devices
- Experience working in a GXP environment.
- Strong critical thinking to be able to interpret complex regulations and

discern critical issues.
- Ability to manage competing priorities and deliver critical information in a

timely manner.
- Effective organizational, planning and negotiation skills.
- Proven ability to work effectively in a team environment.
- Strong interpersonal skills with the ability to build strong working

relationships and manage internal and external stakeholders.
- Ability to work independently on multiple tasks in a fast-paced environment.
- Strong decision-making and analytical skills.

**What we offer**
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday

**What next?**
As a growing business we're looking for likeminded people to join us - we hope that's you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full Australian working rights to be considered
- At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality._