Regulatory Affairs Manager

BD

Macquarie Park

1 week ago

Macquarie Park

1 week ago

Apply

Regulatory Affairs Manager

BD seeks an experienced Regulatory Affairs Manager to lead regulatory strategy and enable market access across Australia and New Zealand on a 12-month maternity leave contract. The role provides strategic regulatory direction across Medical, Connected Care and Interventional portfolios, overseeing submissions and team leadership.

Apply

On-site

Full-time

Entry Level

Salary

Not specified

Work Location

Macquarie Park, New South Wales, Australia, AU

Work Model

On-site

Employment Type

Full-time

Experience Level

Not Applicable

Contract Length

12 months

Core Qualifications

Soft Skills

people leadershipstakeholder engagementinfluencingproblem-solvingdecision-makingroot cause analysiscollaborationcommunicationstrategic thinking

Key Responsibilities

•Providing strategic regulatory direction and monitoring submission progress across ANZ
•Leading and developing the Regulatory Affairs team
•Partnering with local Business and Functional leaders to align regulatory strategy with commercial goals
•Managing regulatory activities to ensure compliance with TGA, Medsafe, DAFF and NZ MAF
•Overseeing preparation and submission of general marketing applications to TGA and Medsafe
•Maintaining relationships with regulatory authorities and industry bodies
•Supporting business with regulatory input into promotional plans and training
•Ensuring promotional materials comply with regulatory requirements and Code of Practice
•Providing ANZ regulatory expertise to regional and global stakeholders
•Contributing to regional and international regulatory networks and initiatives

Regulatory AffairsANZMedical DevicesMaternity Leave ContractLeadershipTGAMedsafeAustraliaNew ZealandBD

Key Responsibilities

•Providing strategic regulatory direction and monitoring submission progress across ANZ

•Leading and developing the Regulatory Affairs team

•Partnering with local Business and Functional leaders to align regulatory strategy with commercial goals

•Managing regulatory activities to ensure compliance with TGA, Medsafe, DAFF and NZ MAF

•Overseeing preparation and submission of general marketing applications to TGA and Medsafe

•Maintaining relationships with regulatory authorities and industry bodies

•Supporting business with regulatory input into promotional plans and training

•Ensuring promotional materials comply with regulatory requirements and Code of Practice

•Providing ANZ regulatory expertise to regional and global stakeholders

•Contributing to regional and international regulatory networks and initiatives