Full Time Regulatory Affairs Associate

3 weeks ago

Castle Hill, Australia KSJ GROUP PTY LTD Full time

KSJ GROUP PTY LTD

Address: Castle hill, NSW 2154

Full Time Regulatory Affairs Associate

Salary $75,000 to $85,000 excluding superannuation

Are you passionate about ensuring the safety and compliance of pharmaceutical products? Do you have experience in Pharmacovigilance? We are seeking for a Regulatory Affairs Associate with

Pharmacovigilance experience to join our dynamic team. As a key member, you will play a crucial role in managing regulatory processes and maintaining compliance with health authorities.

**Responsibilities**:

- Lead and deliver regulatory submissions within required timeframes and consistent with TGA and Medsafe requirements.
- Ensure maintenance of allocated portfolio by carrying out activities associated with the change control process for CMC, artwork and labelling (Product Information).
- Collaborate with team members to develop regulatory strategies for allocated portfolio and new medicine submissions.
- Respond to TGA and Medsafe questions by liaising with local/global functions and external partners.
- Maintain database systems in compliance with internal requirements.
- Build and maintain effective collaboration with TGA and Medsafe personnel and other internal and external stakeholders.
- Keep up to date with new TGA and Medsafe requirements and processes.
- Contribute to departmental projects as required.
- Collect, process, document, report, and follow up on adverse event reports.
- Assist in the preparation, negotiation, approval, and maintenance of pharmacovigilance

agreements.
- Efficiently process orders related to regulatory affairs.
- Support internal and external audits, corrective action plans, and Health Authority inspections.
- Work closely with other local departments to ensure seamless operations. Capacity to

investigate and evaluate a problem to develop effective solutions.
- Excellent communication skills (written and verbal).
- Ability to multitask and work to deadlines.
- Demonstrated ability to work well in a team environment and co-operate with others to achieve goals within specified timeframes

The minimum qualifications and experience for this role are:

- Bachelor’s degree or equivalent in Pharmacy or Chemistry or Life Sciences. Pharmacy is

preferred.
- Familiarity with local (Australia and New Zealand) and international regulatory guidelines.
- Experience in regulatory with an awareness on TGA and Medsafe requirements and

Pharmacovigilance with an ability to assess the case reports with awareness on TGA and

Medsafe PV guidelines.

**Job Types**: Full-time, Permanent

Pay: $75,000.00 - $85,000.00 per year

Schedule:

- Afternoon shift
- Day shift
- Monday to Friday
- Morning shift

**Education**:

- Bachelor Degree (preferred)

**Experience**:

- regulatory with an awareness on TGA and Meds: 1 year (preferred)
- Pharmacovigilance: 1 year (preferred)

Work Authorisation:

- Australia (preferred)

Work Location: In person

Application Deadline: 12/05/2024

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