Regulatory Affairs Compliance Associate
3 days ago
**Benefits**
- Work for a leading Pharmaceutical company
- Challenging Regulatory role with a collaborative team
- Part time position - competitive salary package on offer + benefits
**About the company**
Our client is a global pharmaceutical company who is committed to improving and extending people's lives through medical science and digital innovation.
**About the opportunity**
As a Regulatory Affairs Compliance Associate, you will be responsible for ensuring regulatory compliance in accordance with our client's processes, procedures, and systems, as well as relevant Australian and New Zealand legislation and guidelines. You will handle regulatory information, manage mailboxes, and oversee the change control process from a regulatory affairs perspective. You will work collaboratively with various stakeholders to ensure that our client maintains its high standards of quality and compliance.This is a part time position with an opportunity to WFH.
**Duties**
- Handle regulatory information using our client's Regulatory Information Management tools.
- Ensure key operational trackers are kept up-to-date and that information is entered with consistency by RA Associates
- Manage department’s mailboxes and triage incoming data packages
- Validate pre and post approval activities to ensure compliance with health authority requirements are met
- Oversee change control process from Regulatory Affairs perspective, collaborating with QA and Supply Chain
- Perform and respond to Global Regulatory Compliance Checks and liaising with local QA and Supply Chain on resolving supply issues
- Conduct risk analyses, develop effective procedures and tracking tools
- Provide assistance and support in preparation for and during the course of internal and external audits and inspections of RA operations
**Skills and Experience**
- Tertiary qualified - Pharmacy or Science
- Relevant postgraduate qualification would be considered an advantage
- Experience working within the Pharmaceutical Industry with a strong understanding of compliance standards in Regulatory Affairs
- Strong understanding of quality systems and Australian and New Zealand regulations
- A thorough working understanding of regulatory compliance
- Strong communication and ability to work cross functionally
**Culture**
Our client is committed to fostering a diverse, equitable, and inclusive environment that inspires new ways of working. Their culture is underpinned by integrity, curiosity, and flexibility.
**How to Apply**
**Job details**:
- Location
- Sydney
- Salary
- Competitive
- Job Type
- Part Time
- Ref
- BH-39822
- Contact
- Gemma Staddon
- Contact phone
- +612 8877 8776
- Posted
- 26 minutes ago
-
Regulatory Affairs Associate Compliance
1 day ago
Sydney, Australia Novartis Full time5 million. This is the number of products that Sandoz, a part of the Novartis Group of Companies, distributes into the Australian & New Zealand market every single month. Join the Team of the Year at Sandoz ANZ where you can actively contribute to this number by assisting the regulatory feasibility assessments, formulating submission strategies and...
-
Regulatory Affairs Associate
7 months ago
Sydney, Australia Viatris Full time1488 Alphapharm Pty. Ltd. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless...
-
Regulatory Affairs Associate
20 hours ago
Sydney, Australia Viatris Full time3801 Upjohn Australia Pty Ltd. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines...
-
Regulatory Affairs Associate
6 days ago
Sydney Central Business District, Australia HAYS Full timeThis is a Regulatory Affairs role based in North Sydney to support maintenance and new product submissions **Your new company** This Australian-based global company is known for their reputable and innovative OTC and complementary products. Based in Sydney's North. Our client has a extensive portfolio of well known household brands their focus is on...
-
Regulatory Affairs Associate
2 months ago
Sydney, Australia Colgate-Palmolive Full timeNo Relocation Assistance Offered Job Number #163782 - Sydney, New South Wales, Australia **Who We Are** Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the...
-
Regulatory Affairs Associate
20 hours ago
Sydney, Australia Pfizer Full timeWhy Patients Need You This is a great opportunity to become part of a dedicated and successful Regulatory Department and to help us make a meaningful difference to the lives of patients in Australia and New Zealand. Our Team is talented, collaborative, diverse and made up of experienced regulatory professionals who always strive for the best outcomes for...
-
Regulatory Affairs Associate
7 months ago
Sydney, Australia Healthcare Professionals Group Full time**Benefits** - Great role to join a collaborative Medical Device organisation. - Exposure to diverse medical device portfolio - Hybrid working environment **About the Company** Our client is a leading Medical Device organisation with a strong presence in Australia, New Zealand, and Asia - they have a focus on quality and dedicated support, the company has...
-
Regulatory Affairs Specialist
1 month ago
Sydney, New South Wales, Australia Stryker Full timeBased in Australia, this Senior Regulatory Affairs Associate role at Stryker presents an exciting opportunity to join a high-performing team in the medical device industry. With a strong focus on regulatory compliance, you will be responsible for preparing and submitting device registration applications, including complex submissions such as Class III and/or...
-
Snr Regulatory Affairs Associate
7 months ago
Sydney, Australia S2M Digital Full time**Job Type**: - Full Time**Location**: - Sydney NSW**Classification**: - Legal**Sub Classification**: - Lawyer - Compliance**Reference #**: - 3684598**Contact Name**: - Brett Dickinson- **Salary**: - $130,000.00 - $165,000.00 Year Up to $160k packageAre you a Regulator Affairs Associate looking for a step up, or a Snr Regulatory Affairs Associate and...
-
Regulatory Affairs Manager
3 days ago
Sydney, Australia GWF Full timeAmazing career development opportunities within the GWF business - Be a part of an iconic brand! - North Ryde based with flexible hybrid working options Tip Top is currently looking for a Regulatory Affairs Manager to be based in North Ryde, to lead the Regulatory Affairs function by partnering with relevant internal and external business stakeholders to...
-
Regulatory Affairs Associate
3 days ago
Sydney, Australia Healthcare Professionals Group Full time**About the Company** A distinguished Australian medical device company that manufactures and distributes a vast range of medical devices and surgical products. The company strives to offer innovative solutions to make a difference to patients lives. They have a collaborative culture and pride themselves on their environmentally sustainable...
-
Regulatory Affairs
6 months ago
Sydney, Australia 4C Recruitment Full timeASX listed complementary healthcare manufacturer - Busy, project driven environment - Western Sydney - work closer to home Immediate opening for Reg Affairs professional with experience in complementary healthcare sector and excellent experience and understanding of TGA compliance. Growing business offering a growing pipeline of new products. **Key...
-
Regulatory Affairs Associate
6 days ago
Sydney, Australia Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?**: If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are also reimagining the most important aspects of our work lives and creating more...
-
Regulatory Affairs Specialist
7 months ago
Sydney, Australia Medella Life Full timeLocation- Sydney- Contact name: - Ethan Keating- Job ref: - 827- Published: - about 2 hours ago**Job Title: Regulatory Affairs Specialist (12-month Contract)** **Location: Hybrid - Sydney, Australia** **Key Responsibilities**: - **Regulatory Compliance**: - Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector,...
-
Regulatory Affairs Associate
7 months ago
Sydney, Australia Lula Group Full timeHybrid 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....
-
Regulatory Affairs Specialist
3 days ago
Sydney, New South Wales, Australia Stryker Full timeAbout the RoleStryker is seeking a highly skilled Regulatory Affairs Specialist to join its regulatory team in Australia. As a Senior Regulatory Affairs Associate, you will be responsible for preparing and submitting device registration applications, reviewing change notifications, and providing strategic regulatory advice.Key Responsibilities:Prepare and...
-
Regulatory Affairs Associate, Health
7 months ago
Sydney, Australia Reckitt Full timeWant to see your expertise recognised? As a Regulatory Affairs Associate you’ll have the freedom to influence decisions that shape our next generation of leading brands. Regulatory Affairs Associate Sydney Based Position - WFH/Office Hybrid Environment Competitive Salary & excellent benefits package Critical for driving innovation and optimising our...
-
Regulatory Affairs Manager
7 months ago
Sydney Central Business District, Australia Robert Half Full timeRegulatory Affairs Manager for a top 10 Insurance Firm in Australia. Financial Services, Regulatory Affairs, Insurance The Company Multi-award-winning large insurance firm based in Sydney with an excellent, inclusive culture with best-in-class flexibility. The company have won awards for being one of the best places to work due to their wellness...
-
Manager, Regulatory Affairs
3 months ago
Sydney, Australia HSBC Full time-Job description **Some career choices have more impact than others.** At HSBC we exist with the purpose of Opening up a World of Opportunity. We use our unique expertise, capabilities, breadth and perspectives to provide opportunities for our customers and colleagues through global connectivity. We bring together the people, ideas and capital that nurture...
-
Regulatory Affairs Manager
6 months ago
Sydney, Australia PERSOLKELLY Full timeIf you are passionate about developing complementary medicines and nutritional supplements, this job is for you! **ABOUT THE ROLE**: PERSOLKELLY have an exciting opportunity for a Regulatory Affairs Manager to further their experience within the pharmaceutical industry. Our client is an established Pharmaceutical Manufacturer that specialises in...