Regional Director of Regulatory Affairs and Pharmacovigilance
1 month ago
Healthcare Professionals Group is seeking a highly skilled and experienced Regional Director of Regulatory Affairs and Pharmacovigilance to lead and shape regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.
About the Opportunity
This newly created role is targeted at a seasoned professional with extensive experience in Regulatory Affairs across ANZ and ideally the APAC region. The ideal candidate will have strong people leadership experience, with the ability to flex between strategic and tactical execution.
Key Responsibilities
- Lead a team of senior regulatory professionals while developing and executing regulatory strategies to drive product portfolio expansion.
- Oversee regulatory compliance across the ANZ and APAC regions throughout the product lifecycle.
- Prepare and manage submissions for products to relevant authorities, including the Therapeutic Goods Administration (TGA) in Australia, Medsafe in New Zealand, and HSA in Singapore.
- Collaborate with global business partners to navigate complex regulatory pathways.
- Act as the regional expert and local QPPV for Pharmacovigilance (PV) with TGA.
- Lead and manage PV activities, ensuring full regulatory compliance.
Requirements
- Extensive experience in Regulatory Affairs across ANZ and ideally the APAC region.
- Strong people leadership experience, with the ability to flex between strategic and tactical execution.
- Experience and/or exposure to leading Pharmacovigilance / Drug Safety.
- Ability to develop and lead a high-performing team of Regulatory and Pharmacovigilance professionals.
- Proven experience leading diverse teams and driving strategic regulatory initiatives.
- Tertiary qualifications in science and/or related field.
About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care.
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