Regulatory Affairs Manager, Advanced Surgery
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Overview
We are seeking a highly skilled Regulatory Affairs Manager to join our Advanced Surgery business at Baxter. In this role, you will be at the forefront of crafting and enacting regulatory strategies for our Advanced Surgery portfolio. You will coordinate regulatory initiatives across Australia and New Zealand, while also leading all aspects of broader strategies within the APAC region, excluding Japan and China.
Reporting
Reporting to the Senior Director, Regulatory Affairs, your key accountabilities will include ensuring regulatory compliance with relevant requirements and guidelines, providing guidance on strategic projects and initiatives, and developing and justifying sound regulatory decisions that support business objectives. Additionally, you will be responsible for managing effective communication and relationships with ANZ regulatory authorities, as well as providing regulatory guidance and support to the Advanced Surgery commercial business operations within the region.
Key Responsibilities
- Develop and implement regulatory strategies for intricate projects, covering new products and maintaining licenses for existing products in ANZ.
- Develop and put into effect regulatory strategies for the APAC region (excluding Japan and China).
- Identify and prioritize key areas of risk, developing and implementing appropriate mitigation plans.
- Monitor applicable regulatory requirements to ensure compliance with Baxter and external standards.
- Perform gap analysis on regulatory documentation, proposing solutions and identifying areas for improvement.
- Establish effective communication within the Regulatory Affairs (RA) department, with local Marketing, and other functions primarily at the project level, promoting proactive communication.
- Ensure regulatory strategy and deliverables are aligned with project teams and business objectives.
- Manage regulatory tasks for the Advanced Surgery product portfolio.
- Prepare, review, and approve labeling, SOPs, and AdProm materials for compliance with ANZ regulations.
- Supervise the operational elements of the Regulatory Information Management system, covering registrations, submissions, and data lifecycle management.
- Represent or lead the RA function on assigned cross‑functional project teams.
- Lead all aspects of and coordinate regulatory actions for Advanced Surgery in the APAC region (excluding Japan and China).
- Serve as the face of Regulatory Affairs within the Advanced Surgery VP of APAC’s leadership team.
Key Requirements
- 5‑10 years experience in regulatory affairs within the medical device or pharmaceutical industry.
- Solid understanding of ANZ regulatory requirements and familiarity with APAC region regulations.
- Master’s degree/PhD in a relevant field; advanced degree or equivalent experience is a plus.
- Exceptional proficiency in crafting and implementing compliance plans for intricate projects.
- Excellent communication and interpersonal skills to work effectively within cross‑functional teams.
- Demonstrated ability in problem‑solving and effectively handling various tasks.
- Excellent focus on details and the capability to operate autonomously.
- Working experience with Regulatory Information Management systems is desirable.
- Strong technical and management skills.
- Ability to lead and mentor others.
- Ability to independently identify compliance risks and elevate when necessary.
Location
Sydney, New South Wales, Australia
Benefits & Culture
At Baxter ANZ, we are focused on being a Best Place to Work where our people can be their authentic self, feel valued and respected. Inclusion, diversity, and collaboration are core to our culture.
Equal Employment Chance
Baxter is an equal opportunity employer and evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation, please let us know.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams. Please review our Recruitment Fraud Notice.
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