Description

About the Position Senior Regulatory Affairs Associate– Pharmaceuticals

CS Executive Group Inc. ChemSkill Pharmaceuticals&Medical Devices (Healthcare&Medical) Full time $100K - $130K plus super based on experience Our client's head office is based in the UK and have now expanded into the ANZ region with a Head Office in Adelaide and additional locations in Melbourne, , and Auckland, New Zealand, focusing on cGMP. With an existing distribution centre in Australia, our client is in the midst of building a manufacturing centre on our shores!Manufacturing an extensive portfolio of

OTC and prescription medicines , the company focuses on quality, compliance, safety, and performance in accordance with their core values and sense of purpose. Additionally, they are committed to sustainability practices with eco-friendly purpose-built facilities. ROLE This position presents an exciting opportunity for a

Senior Regulatory Affairs Associate

to take on a role in a

growing generic and private label OTC and Rx pharmaceutical company

working towards an increasing portfolio of product licenses. The successful candidate will be an active agent in this expansion process. This opportunity will provide an exceptional insight into the development of a new pharmaceutical company, giving you autonomy and broad learning. A once in a career opportunity to be actively involved in the start-up of an aspiring global organisation.Reporting to the

Director of Operations, ANZ , the Senior Regulatory Associatewill be joining a small team in Melbourne that is instrumental in the continued successful expansion of our client into the Australian Market. On offer is a

competitive salary package , commensurate with experience,

Hybrid working arrangement– ideally 1 - 2 days WFH, laptop and a mobile phone . The chief responsibility is to ensure compliance

with regulatory and governing authority requirements

in the ANZ region such as TGA (TGO 91&TGO 92) and Medsafe. This will be achieved through preparing dossiers and submissions for registering of new applications, variations, and reclassifications to Regulatory and Authority bodies in the ANZ region. Some responsibilities include: Liaise with regulatory authorities to achieve the best outcomes for the businessWork with internal departments to ensure compliance with regulatory legislation, guidelines and company processes and procedures Assist in the preparation of SOPs for relevant regulatory activities Partner with Quality Team for site transfer processes Participate in internal and external audits of facilities and suppliersSELECTION CRITERIA To be successful in your application you will need to meet the following selection criteria: A Degree in Chemistry, Pharmaceutical Science or a related discipline 3-10 years of Regulatory Affairs experience Working experience with current TGA&Medsafe requirements for OTC An understanding of current TGA&Medsafe requirements for Prescriptions will be highly regarded Advantageous to understand the current UK and European regulatory requirements High attention to detail&critical thinking Effective oral and written communication skills. Excellent decision making, organisational and planning skills Friendly with a good work ethic and the ability to work independently and within a small team Ability to multitask whilst maintaining quality output and meeting time linesAPPLICATIONS To be considered for this role please apply using the 'Apply' button below and send your updated resume and cover letter to CS Executive Group. For a confidential discussion about this role, please call Helen on 0438 620 434

or Renee on 0403 727 598

or email . THANK YOU We would like to thank you in advance for taking the time to apply for this role. Unfortunately, due to the large volume of applications we receive daily, we typically only make contact with individuals whom we consider as having suitable qualifications and experience to be assessed further for shortlisting.Nevertheless, all resumes submitted to CS Executive Group are retained on our database - you might therefore be contacted by us for suitable roles arising in the future. To view other available roles please visit our website's page: Your application will include the following questions:Which of the following statements best describes your Covid-19 vaccination status? Report this job advert

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