ANZ Special Projects Regulatory Affairs Lead

6 days ago

Council of the City of Ryde, Australia Johnson & Johnson Full time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

All Job Posting Locations: AU008 North Ryde Khartoum Rd

Job Description:

  • Great Place to Work Certified - 2024
  • Competitive salary package, flexible work practices, award winning benefits
  • Continuous training and development

ABOUT THE ROLE

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

THE OPPORTUNITY

Work closely with APAC regional Special Project RA lead, global PMOs & serve as the overall Country Special Project RA lead in ANZ to execute the MD RA Special Project initiatives.

Serve as a key RA lead by demonstrating strong collaboration skills, partnering with key stakeholders and working with leaders at all levels in the organization.

Adherence to J&J CREDO and industry code of conduct, ethics and good regulatory practices, align team members with J&J CREDO. Ensure 100% compliance with local legislation, global regulatory policies, J&J CREDO.

RESPONSIBILITIES

  • Lead ANZ Special Project RA team to develop regulatory strategies for all the special projects by gaining alignments with the internal partners across Johnson & Johnson (including global PMOs, local RA, Supply Chain, Marketing & Quality etc.) to ensure that the stakeholders' voices are evaluated within the strategies.
  • Provide prioritization, capacity management, and efficiency gain options for Special Project program in ANZ.
  • Work collaboratively with country or local Franchise RA leaders to lead executions of all Special Projects.
  • Be accountable for completing Special Project impact assessments on time.
  • Be responsible for completing all the RA actions accurately and on time delivery per project plan.
  • Lead ANZ Special Project RA team to set project plan with the detailed tasks and timeline for each Special project to avoid any registration misses.
  • Ensure timely MDRiM updates for each RA action, SEP dates, license update and code linkage to country license per process SOPs.
  • Be part of APAC Special Project RA leadership team and represent ANZ to work with the team to create and share the best practices on the Special project executions.
  • Be responsible to achieve and maintain the appropriate metrics for ANZ Special Project program per 2025 G&Os.
  • Recruit and hire Special Projects RA resources as needed.
  • Ability to manage multiple priorities is required.
  • Work across the APAC region to create and share the best practices on the execution of the strategy for executing multiple Special projects.
  • Ensure applicable company compliance with all relevant country and regional requirements, company regulations, policies and procedures.
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
  • Effectively lead and coach team members, motivating the group to work more efficiently, manage and develop people and talent, to build a collaborative, high performance team.

ABOUT YOU

  • A minimum of a Bachelor's Degree of Engineering or Science with 7+ years of regulated industry experience, inclusive of regulatory affairs, (OR an advanced degree with 5+ years) is required.
  • Medical Device industry experience is preferred.
  • Previous experience managing, or leading projects is required.
  • Excellent written and verbal communications skills in English are required.

COMPANY CULTURE

  • 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.

WHY CHOOSE US:

  • Competitive remuneration package and continuous training.
  • Supportive environment with award-winning leadership development programs.
  • Inclusive, flexible, and accessible working arrangements for all.

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 prioritize 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...

Great Place to Work Certified– 2024
Great Place to Work Certification recognises employers who create outstanding employee experience. The certification process is recognised worldwide as the global benchmark for identifying outstanding workplaces.

Johnson & Johnson - Australia and New Zealand was certified as a Great Place to Work in ANZ in its first year of participation.

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