Regulatory Affairs Associate
As our Regulatory Affairs Associate, you will prepare applications and submissions, so that appropriate patient and business outcomes are achieved!
Summary about this job
Pharmaceuticals & Medical Devices
Company: Novartis Pharmaceuticals Ltd
Location: Sydney
Work type: Contract/Temp
Salary: Base salary + completion bonus
Phone: +61-2-7453-1197
Fax: +61-7-9848-4518
E-mail: n\a
Site: n\a
Detail information about job Regulatory Affairs Associate. Terms and conditions vacancy
- 9 month contract with an early October start date
- Work across all Novartis products in Australia and NZ
- Bring clinical experience & familiarity with Medical Information
As our Regulatory Affairs Associate, you will prepare submissions to maintain registration of approved products, as well as expand their use in Australia and New Zealand, so that appropriate patient and business outcomes are achieved.
- Prepare regulatory applications to extend use (indications, dosage, new strengths, addition of new clinical data to the PI etc.) of registered Novartis and Alcon Pharma products and maintain registration in accord with legislation and Novartis standards
- Prepare submissions to TGA/Medsafe including, but not limited to, Category 1 and 3 Applications, SRR with/without data, change medicine notifications, GMP clearances, PSURs, RMPs.
- Provide regulatory support to the business under the guidance of RA Manager. Work in cross-functional teams to provide regulatory support and expertise.
- Keep accurate records of all health authority correspondence as well as key internal communications.
- Review promotional material for compliance with relevant laws, guidelines, codes of conduct and policies.
- Support regulatory risk mitigation strategies as needed (eg. Stock-out).
- Liaise with internal subject matter experts to respond to submission deficiencies identified during regulatory review.
- Follow all internal SOPs and guidelines assigned to RA
- Ensure regulatory issues with business impact are communicated to RA Manager and Head of RA GDD in a concise, accurate and timely manner and recorded in relevant systems.
- Monitor adverse reactions and product complaints, maintain appropriate records and report any significant findings
About You:
You’ll have a strong Regulatory background, with the ability to manage a portfolio of around 60 products, end-to-end. You get to work on everything – so you’ll be a big multitasker, flexible, and able to cope with changing priorities. You are solutions focused and full of initiative, and know how to drive to get results. Nothing overwhelms you and you are comfortable managing several different internal stakeholders.
Successful candidates will also have:
- Excellent written and spoken communications skills, with confidence in building strong scientific justifications
- Previous experience dealing with TGA and MedSafe
- Familiar with Product and Consumer Medical Information – strong clinical expertise
- Tertiary education in Pharmacy, Science, Chemistry or related area
Join a large Regulatory team within a global leader. Apply today!