Regulatory Affairs Manager

• 2024 Best Places to Work - #1 in Health Industry
• Competitive salary package, flexible work practices, award winning benefits
• Continuous training and development
• Strong and exciting pipeline!
• Location: Office based in Macquarie Park and remote options available for non-Sydney based flexible work practices

ABOUT THE COMPANYAt 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 https://www.jnj.comTHE OPPORTUNITYJohnson & Johnson is looking for a Regulatory Affairs Manager to join the Regulatory Affairs (RA) team, reporting into the Senior Manager, Regulatory Affairs. You will make a positive impact on patients in Australia and New Zealand, through providing regulatory leadership of a portfolio of products. You will form part of our RA Leadership Team, and also take on people leadership responsibilities in the future.Our Regulatory Affairs team are very skilled and passionate individuals committed to getting the best outcomes for the patients and the customers that we serve. Working in the pharmaceutical industry, you will be exposed to a broad range of products that will have life changing effects on patients' quality of life. We are committed to create a culture where we all feel valued and heard, and a place where we can all build new skills and capabilities and grow our careers.If you are excited by and have experience in Regulatory Affairs and people leadership and would like to be exposed to a broad range of therapy areas and development opportunities, this role is for you.RESPONSIBILITIES

• Lead a product portfolio to plan regulatory strategies and manage local regulatory submissions for Australia and New Zealand, including new product registrations, new indications, and line extensions.
• Also provide people leadership in the future, including coaching and development of Regulatory professionals.
• Liaise proactively and work collaboratively with global, regional, and local colleagues in the management of applications throughout the submission and evaluation processes to ensure a high quality and timely outcome, with the optimum labelling.
• Lead regulatory assessments for early pipeline products and new technologies.
• Be an active member of the cross-functional teams to lead regulatory discussions, including the development and execution of strategies for pipeline products to optimise and accelerate launch excellence.
• Initiate and lead ad-hoc projects, including responses to TGA/Medsafe consultations and process improvements.
• Active sharing of learnings, experiences and best practices to help the Regulatory Affairs team to grow together as a team.
• Ensure all relevant work is undertaken in compliance with local regulation requirements and local and global corporate standards.
• Develop and maintain in-depth knowledge of regulations/legislation and keep up to date with changes in the regulatory environment.

This is an exceptional opportunity to take the next step on your leadership journey and realise your potential in a collaborative and inclusive organisation that will support your future development and career aspirations.

• A Bachelor's Degree in Pharmacy or Science or related field, and any additional qualifications such as a PhD or Masters would be highly regarded.
• Extensive experience in prescription medicines Regulatory Affairs within Australia and New Zealand and experience in new products, i.e., Category 1 and New Medicine Applications is required.
• Demonstrated strong technical expertise including in-depth knowledge of regulations/legislations and negotiation skills working with the TGA and Medsafe.
• People leadership experience is required, including demonstrated ability to coach and develop talent.
• Strong project management skills including critical thinking and problem solving, negotiation, time management and risk management.
• Proven leadership skills including ability to take accountability, openness to feedback, resilience when challenges arise and vision to reach the end goal.
• A natural growth mindset - you thrive on challenge and see failure as a springboard for growth and developing your abilities.
• Positive can-do attitude and are self-motivated with a sense of urgency.
• Excellent verbal and written communication skills.
• Extremely strong ethical values.

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 $720 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...Closing date: 30th June 2024For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.Agencies please note: This recruitment assignment is being managed directly by Johnson & Johnson's Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.