Job Title

Senior Regulatory Affairs Associate | multiple launches! | MEL basedJoin to apply for the Senior Regulatory Affairs Associate | multiple launches! | MEL based role at Heng & Hurst.Join a leading international biopharmaceutical company who is seeking an experienced Senior Regulatory Affairs Associate to support its continued growth and commitment to delivering innovative therapies. With a strong presence across ANZ and SEA, the organisation is known for its strategic approach to commercialisation, regulatory expertise, and dedication to excellence.Reporting to the Head of Regulatory Affairs, this role is responsible for ensuring successful regulatory submissions and approvals across Australia, New Zealand, and the SEA region.Your Key Responsibilities Include:Preparing and managing regulatory dossiers for submission to the TGA, Medsafe, and other regional authorities.Leading interactions with regulatory agencies, licensing partners, and external consultants to facilitate approvals.Working end-to-end on Category 1 submissions.Ensuring ongoing compliance by managing variations and renewals.Collaborating cross-functionally with Medical, Quality, and Commercial teams to support product launch activities.Staying updated on local regulations and providing guidance on regulatory best practices.The Ideal Candidate Will Have:5+ years experience in regulatory affairs within the pharmaceutical industry.Strong knowledge of TGA guidelines, processes, and regulatory frameworks in the ANZ Market.Strong knowledge of the Cat 1 submission.Exposure to New Zealand and/or SEA regulatory systems (highly advantageous).Excellent communication and stakeholder management skills.A keen eye for detail, the ability to work independently, and strong problem-solving abilities.This is an opportunity to make an impact within a growing biopharma company committed to innovation. Work in a collaborative and agile environment with key stakeholders to drive successful product launches with career growth opportunities across multiple regions and therapeutic areas.This is an excellent opportunity for an experienced regulatory professional seeking to contribute to a dynamic and forward-thinking organisation.Applications should be submitted in WORD format, or contact Jasmine Garbino on 0460 947 804 for a confidential discussion.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionScienceIndustriesStaffing and Recruiting #J-18808-Ljbffr