Regulatory Operations Leader

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $124,558 - $173,844
Job Title

RIO Execution Hub Manager


About the Job

We are seeking a seasoned Regulatory professional to assume the role of RIO Execution Hub Manager. This position requires strong leadership and communication skills, with the ability to work effectively across different clusters and/or regions.

The ideal candidate will have a proven track record in regulatory support, with expertise in managing complex regulatory activities. Strong technical knowledge of pharmaceutical organizational structures, systems, and culture is essential for success in this role.

In this capacity, you will provide critical on-the-job deliverables that drive business results, while bringing efficiencies to the organization through portfolio execution.

This is an exciting opportunity to join our team and contribute your skills and experience to help us achieve our goals.

Responsibilities
  • Provide regulatory support for assigned cluster/country under his/her responsibility for RIO Execution Hub Team Lead and key stakeholders, including the Country Regulatory Strategist and Hub Submission manager, for the processes under his/her responsibility.
  • Ensure timely delivery of local M1 dossier components.
  • Act as the initial point of contact for assigned cluster/country under his/her responsibility for RIO Execution Hub Team Lead and key stakeholders, including the Country Regulatory Strategist and Hub Submission manager, for the processes under his/her responsibility.
Requirements
  • B.S./B.Scs. in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
  • Advanced to Fluent English language required. Multilingual skills desirable.
  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
  • Advanced Microsoft Office Suite skills.
  • Familiarity with pharmaceutical organizational structures, systems, and culture.
  • An understanding of country/cluster regulatory requirements and trends is preferred.
  • Relevant experience within pharma, in Regulatory, quality and/or compliance fields.

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