In-Demand Regulatory affairs Jobs in Parramatta, Nsw

Quality Assurance Senior Manager
Clinigen —Sydney NSW
- Full-time
- Analysis skills
- Bachelor's degree
- Leadership
Quick Apply
Area Strategic Planning Manager
British American Tobacco —Sydney NSW
- Finance
- Master's degree
- Bachelor's degree
- Health insurance
- Parental leave
Government Affairs and Media Manager (AU)
DroneShield Limited —Sydney NSW
- Full-time
- Management
- Writing skills
Quick Apply
Senior Legal Counsel
NAB —Sydney NSW
- Full-time
- Organisational skills
- Time management
13d
Medical Partner (Medical Manager) - Ophthalmology - 12 Months Max Term Contract
Roche —Sydney NSW
- Contract
- Medicine
- Doctoral degree
- AI
5d
Pharmacovigilance Project Manager (Japanese fluency required)
PrimeVigilance —Sydney NSW
- Full-time
- Leadership
Quick Apply
Post Market Lead
EBOS Group —North Ryde NSW
- Full-time
- Hybrid work
- Health insurance
- Parental leave
5d
MCO Medical Lead - Paediatric Vaccines
Sanofi —Sydney NSW
- Medicine
- Doctoral degree
- Marketing
Post Market Vigilance Lead
Device Technologies Australia —Sydney NSW
- Full-time
- Communication skills
Legal Counsel - 12 Month Contract
MetLife —Sydney NSW
- Temporary
- Financial services
- Parental leave
- Employee assistance program
Mechanical Engineer
ResMed —Sydney NSW
- Full-time
- CAD
5d
Senior Counsel
Visa AP (Australia) Pty Ltd —Sydney NSW
- Full-time
- Management
- No experience needed
- Analysis skills
Assistant Manager, Industry Affairs
International Air Transport Association (IATA) —Sydney NSW
- Contract
- Hybrid work
- English
- Bachelor's degree
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Legal Counsel - Technology
Allianz —Sydney NSW
- Full-time
- Hybrid work
- Bachelor's degree
- Agile
- AI
2d
PR & Media Relations Specialist
Woolworths Group —Bella Vista NSW
- Full-time
- Hybrid work
- Communication skills
Engineer II, Reprocessing Engineering (1 year Fixed Term Contract)
ResMed —Sydney NSW
- Full-time
- Engineering
- Bachelor's degree
- Cleaning
Data Center Energy Lead, Australia
Anthropic —Sydney NSW
- Hybrid work
- Education
- Bachelor's degree
- AI
- Parental leave
13d
Product Manager - Cardiothoracic Surgery
Device Technologies Australia —Sydney NSW
- Full-time
- Management
- Sales
- Marketing
Senior Specialist, Medical Science Liaison
Organon —Sydney NSW
- Full-time
- Medicine
- Doctoral degree
- Writing skills
Quick Apply
Senior Solicitor, Licensing
The Law Society of NSW —Sydney NSW
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Microsoft Access
Quick Apply

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regulatory affairs jobs near parramatta, nsw

Quality Assurance Senior Manager

Clinigen -
Sydney NSW

Quick Apply

Job Details

Full-time

Qualifications

Analysis skills
Quality assurance
Bachelor's degree
Pharmacy
Leadership
Communication skills

Full Job Description

Clinigen is a leading global specialty pharmaceutical and services company dedicated to improving patient outcomes through the secure and timely delivery of vital medicines worldwide. With over 1,100 employees and operations spanning the UK, US, EU, JAPAC, and South Africa, Clinigen continues to experience significant growth and innovation in the pharmaceutical sector.

Position Overview:

We are seeking an experienced and highly motivated Quality Assurance Senior Manager to join our dynamic team. The successful candidate will play a critical role in overseeing the quality assurance functions across multiple divisions, ensuring compliance with applicable regulatory standards and internal policies. This senior management position demands exemplary leadership skills, strategic thinking, and a commitment to fostering a culture of quality and continuous improvement within the organization.

Key Responsibilities:

Provide strategic leadership and direction for all Quality Assurance activities within Clinigen to ensure compliance with GxP regulations and other relevant quality standards.
Develop, implement, and maintain quality management systems that support the company’s operational and commercial objectives.
Lead and mentor a team of quality professionals, promoting professional development and high performance.
Ensure readiness for regulatory inspections and client audits, including managing audit responses and corrective action plans.
Collaborate cross-functionally with departments such as Regulatory Affairs, Manufacturing, and Distribution to embed quality principles throughout the business.
Monitor and report on quality metrics, driving continuous improvement initiatives and risk mitigation strategies.
Ensure compliance with applicable legislation including the Misuse of Drugs Act, EU Falsified Medicines Directive, and other relevant regulations.

Requirements

Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced qualifications or certifications in Quality Assurance are highly desirable.
Extensive experience (minimum 8 years) in Quality Assurance within the pharmaceutical industry, including experience in a senior management capacity.
In-depth knowledge of global pharmaceutical regulations including GxP, GDP, EU legislation (EudraLex), and the Human Medicines Regulations.
Proven ability to lead and develop high-performing teams within a regulated environment.
Strong analytical, problem-solving, and decision-making skills with a strategic mindset.
Exceptional communication and interpersonal skills, capable of influencing stakeholders at all levels.
Experience managing regulatory inspections and client audits successfully.
Demonstrable commitment to continuous improvement and quality culture enhancement.
Ability to manage multiple priorities effectively under tight deadlines.

Benefits

In return for your valuable contributions and commitment to our organization, we are pleased to offer you an attractive and comprehensive benefits package that includes:

A competitive monthly salary that reflects your experience, skills, and the industry standards, ensuring that you are fairly compensated for your hard work and dedication.
A performance bonus designed to reward exceptional performance and achievements, providing you with additional financial incentives as you excel in your role.
Ongoing professional development opportunities, including training programs, workshops, and access to resources that will help you enhance your skills and advance your career within our organization.

Quick Apply

Refine Your Search

regulatory affairs jobs in parramatta, nsw

Quality Assurance Senior Manager

Area Strategic Planning Manager

Government Affairs and Media Manager (AU)

Senior Legal Counsel

Medical Partner (Medical Manager) - Ophthalmology - 12 Months Max Term Contract

Pharmacovigilance Project Manager (Japanese fluency required)

Post Market Lead

MCO Medical Lead - Paediatric Vaccines

Post Market Vigilance Lead

Legal Counsel - 12 Month Contract

Mechanical Engineer

Senior Counsel

Assistant Manager, Industry Affairs

Legal Counsel - Technology

PR & Media Relations Specialist

Engineer II, Reprocessing Engineering (1 year Fixed Term Contract)

Data Center Energy Lead, Australia

Product Manager - Cardiothoracic Surgery

Senior Specialist, Medical Science Liaison

Senior Solicitor, Licensing

I want to receive the latest job alert for regulatory affairs in parramatta, nsw

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