facebook

Job details

Location
Sydney
Salary
Attractive salary and benefits package
Job Type
Full Time
Ref
BH-40765
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
7 months ago

Job details

Location
Sydney
Salary
Attractive salary and benefits package
Job Type
Full Time
Ref
BH-40765
Contact
Gemma Staddon
Contact email
Email Gemma
Contact phone
+612 8877 8776
Posted
7 months ago
Benefits
• A role for an experienced Regulatory Affairs professional.
• Opportunity for career development and progression within the team.
• Part time option available and competitive salary package on offer.

About the company
Our client is a leading regulatory consultancy - they are renowned locally and have a strong presence in the national market. Their expertise lies in providing regulatory support to various pharmaceutical Industry leaders.

About the opportunity
This is a great role for someone with a background in the pharmaceutical industry to take on a challenging and rewarding role in a fast-paced environment. As a Senior Regulatory Affairs Associate, you will play a crucial role in maintenance activities of prescription products, ensuring compliance with relevant regulations. In this role you will submit timely applications and respond to regulatory agency requests for information.

To be successful in this role, you will need to be results-oriented, self-motivated, and able to work autonomously. You will also need to have a good understanding of the TGA submission process and be able to provide accurate and timely regulatory advice. This is an exciting opportunity to join a close-knit team of professionals who work together manage the lifecycle of products. This role also has the option of being part time (4 days per week).


Duties
• Ensuring timely submission and responding effectively and efficiently to Agency RFIs to achieve a favourable outcome.
• Provide accurate and timely regulatory advice to the business teams.
• Review and approve advertising materials in compliance with regulations.
• Assess and provide regulatory assessment to Change Control Requests in a timely manner.
• Proactively provide accurate and timely regulatory support and advice to local business teams.

**Please note, the ideal candidate has unrestricted working rights in Australia

Skills and Experience
• Tertiary qualifications in a pharmacy or a life science discipline.
• 3+ years of experience working in the Australian pharmaceutical industry with prescription products in a regulatory affairs role.
• Knowledge of Australian Pharmaceutical regulatory requirements and processes, especially CMC.
• Good understanding of the advertising code of practices and some experiences in reviewing promotional materials.
• Effective written and verbal communications.
• Self-motivated & results orientated.

Culture
An incredibly supportive and harmonious team culture that fosters collaboration.

How to Apply
Click apply or contact Gemma Staddon, Specialist Manager, on 02 8877 8776 or Erin Cox, Sourcing Consultant on 02 8877 8734 for a confidential discussion.

Similar jobs

14 days ago

Regulatory Affairs

Senior Regulatory Affairs Associate

  • Sydney
  • Attractive salary and benefits package

Benefits• A role for an experienced Regulatory Affairs professional.• Opportunity for career development and progression within the team.• Part time option available and competitive salary package on offer.About the companyOur client is a leading regulatory consultancy - they are renowned locally and have a strong presence in the nationa...

4 days ago

Regulatory Affairs

Regulatory Affairs Manager

  • Sydney
  • Competitive Salary + Super + Great Benefits

Benefits• Work with a collaborative Regulatory Affairs team• Global biopharmaceutical company • Flexible work arrangements & excellent benefits About the Company This medium specialty global biopharmaceutical company is renowned for its expertise and is dedicated to helping people build healthy families and live better lives.About the Opportunity As the Regul...

22 days ago

Regulatory Affairs

Regulatory Affairs Manager

  • Sydney
  • $160000 - $170000 per annum, Benefits: + Super + Bonus

Benefits• Challenging new role joining an organisation that is growing.• Leadership position mentoring a small team• Great environment with friendly & hard working team • Competitive salary package + Bonus • Supportive work-life balanceAbout the companyJoin a renowned healthcare company dedicated to serving the medical and scientific community, providing innovati...

5 days ago

Regulatory Affairs

Regulatory Operations Specialist

  • Sydney
  • $85000 - $95000 per annum

Benefits• Regulatory operations role with a leading Pharmaceutical organisation • Supportive and collaborative work environment• Hybrid working environment About the CompanyOur client is a global leader in the pharmaceutical industry, specialising in developing innovative medications and therapies. They are renowned for their commitment ...