Assistant Manager Reg Aff, Vision ANZ

Biopharma Asia; Sydney; Hybride; AUD 140 000 - 190 000; Plein temps

Avantages offerts par ce poste

Competitive remuneration package

Continuous training and support

Inclusive, flexible working-arr.ements

Résumé du poste

Johnson & Johnson is seeking an Assistant Manager, Regulatory Affairs ANZ to lead regulatory activities across Australia and New Zealand. You will mentor a team, direct post-marketing lifecycle management and engage with regulators to influence policy.

The role requires a science degree with 6–8 years’ experience, deep knowledge of regional regulations, and strong negotiation skills to ensure legal marketing status of a diverse product portfolio.

Qualifications

• Bachelor's degree in a scientific discipline (Master's preferred).
• 6–8 years' related experience, ideally in medical devices.
• Expert knowledge of regional government regulations.

Responsabilités

• Lead regulatory activities across Australia and New Zealand.
• Mentor a team of regulatory professionals and direct lifecycle management.
• Engage agencies and trade associations to influence regulations.
• Develop regulatory strategies and ensure post-market compliance.

Connaissances

Regulatory Affairs

Regulatory Compliance

Regulatory Strategy

Communication

Problem Solving

Public Policies

Product Licensing

Regulatory Reporting

Strategic Thinking

Formation

Bachelor's degree in a scientific discipline

Master's degree preferred

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

North Ryde, New South Wales, Australia

Job Description

About MedTech

Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalised treatments.

Visit us at https://www.jnj.com/medtech to see how your unique talents will help patients on their journey to wellness.

The Opportunity

As Assistant Manager, Regulatory Affairs ANZ, you'll lead regulatory activities across Australia and New Zealand, ensuring products meet all market legislation and directing post-marketing Lifecycle Management. You'll mentor a team of regulatory professionals, sit on the ANZ Surgical Vision and Vision Care Leadership Teams, and act as a key regulatory expert, engaging agencies and trade associations to influence changing regulations.

Responsibilities

• Direct growth, innovation and post-marketing Lifecycle Management activities, including claims, renewals, labelling and copy clearance
• Lead regulatory strategies and submissions to health authorities, ensuring ongoing post-market compliance
• Partner with regulators and trade associations to resolve issues and influence policy in line with business strategy
• Anticipate emerging risks and drive best-practice regulatory policies, processes and SOPs
• Develop the team, influence as a key leadership team member and manage the department budget

About You

• Bachelor's degree in a scientific discipline (Master's preferred) with 6–8 years' related experience, ideally in medical devices
• Expert knowledge and practical application of regional government regulations
• Sound regulatory and business strategy expertise to gain and maintain the legal marketing status of a product portfolio
• Excellent organisational, communication and negotiation skills, with the ability to influence senior leaders, affiliates, regulators and industry
• Willingness to travel domestically and internationally (approx. 10%)

Why Choose Us:

• Competitive remuneration package
• Continuous training and support
• Award-winning leadership development programs
• Inclusive, flexible, and accessible working arrangements
• Equal opportunity employer supporting diversity and inclusion

Our Benefits:

• Up to 18 weeks of parental leave to support new parents
• 4 days of volunteer leave to give back to the community
• Option to purchase up to 2 weeks of additional annual leave for extra time off
• Enjoy a dedicated Wellbeing Day to prioritise self-care
• Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities
• Access to an Employee Assistance Program for personal and professional support
• Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support
• Life insurance coverage for added peace of mind

And much more...

All applicants must have rights to work in Australia.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking