Senior Regulatory Affairs Associate

i-Pharm Consulting

Senior Regulatory Associate | Sydney | Full-time

We’re partnering with a growing, mid‑sized pharmaceutical company to appoint a Senior Regulatory Associate into their high‑performing, collaborative team

.

If you’re a seasoned RA professional who wants more influence, more autonomy and genuine visibility with senior leaders, this is worth a loo

k.

You’ll work closely with senior management and take full ownership of end‑to‑end regulatory strategy across a diverse portfolio. It’s a fast‑paced role within a high‑performing yet genuinely supportive team, offering plenty of scope to deepen your technical expertise. There’s a true open‑door culture, so you’ll also have the chance to broaden your skill set and learn from experienced colleagu

es.

The opportu

nity

You’ll be a key member of a lean team, trusted to own your work and have a voice in decisions across the busi

ness.

This isn’t a pure “back‑room” execution role - you’ll be involved in decision‑making, problem‑solving and strategic conversations with stakeholders across Scientific Affairs, Quality and commercial

teams.

With the business in a strong growth and transformation phase, there’s plenty of scope to develop and expand your impact as the organisation e

volves.

Key responsi

  • bilitiesLead end‑to‑end TGA submissions, from preparation through to
  • approvalAct as a primary point of contact with regulators (TGA & Medsafe), managing queries and r
  • esponsesProvide regulatory input into business decisions, advising on strategy, risks and
  • pathwaysWork cross‑functionally with Sales, Marketing, Quality and Supply to influence
  • outcomesStay ahead of regulatory and industry changes, contributing to forward planning and in

novation

  • About youStrong, hands‑on TGA e
  • xperienceProven ability to own work end‑to‑end and operate aut
  • onomouslyConfident communicator, comfortable engaging with senior stakeholders and r
  • egulatorsMotivated by opportunities to contribute, influence and keep growing profe

ssionally

Why this role

  • stands outInfluence & ownership – direct involvement in regulatory and business
  • decisionsSenio r exposure – close partnership with experienced leaders across Scientif
  • ic AffairsD evelopment – scope to build strategic and leadership capability, not ju
  • st execu teAutonomy – trusted to manage your portfolio without micro
  • managementGrowth e nvironment – join during an exciting expansion phase with new products comi

ng thro ugh

Title: Senior Regulatory Affair

s Associa teLocation: Sydn

ey (Hyb rid)Salary: $135,000 - $145,000 base

plus super

Contact Keeley Munday at 0426933037 / ***email_hidden*** for more information, or apply di

rectly here.