Manager, Regulatory Affairs & Compliance (Life Sciences & Research)

at  Elias Recruitment

• Continuously improve regulation and governance for ANSTO
• Based at either Lucas Heights (Sydney) or Clayton (Melbourne)
• ANSTO is committed to investing in its people

REQUIREMENTS:

• Law degree.
• Australian citizenship
• Significant experience within ANSTO’s regulatory environment, or in a highly regulated environment.
• Sound understanding of ARPANS Act, Regulations and guidance and associated regulatory requirements.
• Sound understanding of applicable Work Health and Safety and Environmental regulatory requirements.
• Developing understanding of research and animal ethics regulatory requirements
• Demonstrated experience in writing accurate and concise minutes; preparing careful responses reflecting committee decisions on complex issues; preparing advisory notes; dealing with a wide range of people and conveying complex and confidential information in a sensitive yet clear manner
• Experience in providing high level advice to stakeholders, involving the ability to interpret policies and regulatory requirements
• Experience in providing compliance in a highly regulated environment and willingness to develop an understanding of quality management systems as they relate to ANSTO’s operational activities
• The ability to recognise possible points of concern or contention, and to assess how these can be most effectively handled, including the ability to exercise mature judgement and discretion when dealing with confidential and sensitive issues
• Ability to prioritise and carry out a diverse range of competing tasks to a high standard and the ability to work under pressure and to tight deadlines in a dynamic environment
• Strong ability to influence at all levels of the organisation and with external stakeholders.
• Ability to work effectively as part of a team, as well as independently with minimal supervision
• Strong verbal, written and report writing communication skills.

ABOUT THE ROLE

We have a great opportunity where you can play a pivotal role to ensure ANSTO complies with key regulatory requirements. The Manager, Regulatory Affairs & Compliance facilitates ANSTO’s interactions with government agencies, departments, and regulators and contributes to good governance across ANSTO. We are seeking an experienced Regulatory & Compliance Manager with a legal background to partner with business stakeholders to lead and coordinate ANSTO’s engagement with the TGA.

IN THIS ROLE YOU WILL:

• Design, implement, and continuously improve a governance model for ANSTO that supports compliance with relevant regulatory obligations.
• Provide advice on interpretation and application of regulatory obligations to ANSTO’s operational activities to ensure ANSTO obtains appropriate licences and remains compliant with any licence or permit conditions across the organisation.
• Maintain an accurate and up-to-date compliance register in alignment with ANSTO’s enterprise-wide compliance framework and advise on regulatory change management activities.
• Work closely with stakeholders to ensure oversight of all regulatory matters.
• Work closely with business units to support their preparation of regulatory submissions.
• Establish and maintain effective and collaborative working relationships with external regulators.
• Perform the secretariat function of ANSTOs various research committees, including animal research regulations, the ANSTO Animal Care and Ethics Committee and the Australian Synchrotron Animal Ethics Committee
• Work within the Regulatory & Governance function and report to the Senior Manager, Regulatory Affairs and Compliance, who in-turn reports to the General Manager, Regulatory and Governance.