For over 37 years, Aesop has carefully cultivated an inspiring and inclusive environment in which our employees are supported and encouraged to thrive. As a global retail organisation, we offer professional development and advancement opportunities to complement career goals and aspirations.We aim to strike the right balance between people, planet, and profit, actively reducing our footprint on the planet that generously sustains us. So far, this journey has led us to become a certified B Corp. We are collectively committed to building a more sustainable and inclusive society.Aesop is an endorsed employer for all women. See our range of benefits and policies directly at : Aesop - Work180 Endorsed Employer.Role PurposeAesop are seeking a dynamic and results-driven Senior Manager, Regulatory Affairs with proven experience to join us for 12-months. This role will be operating with a hybrid working pattern, based at our global head office in Collingwood.Reporting into our Head of Technical and Regulatory Affairs, you will lead the Regional Regulatory Affairs function (APAC), over the product lifecycle from pre-market concept, product development, registration, artwork, post-market advertising compliance and vigilance activities.With proven people management skills, you will strategically manage, coach, and provide guidance to the Regional Regulatory Affairs teams. You will also look to embed risk management, regulatory intelligence, and continual improvement programs.The nature of this role requires an individual that is comfortable working autonomously but also the flexibility in working hours/arrangements to accommodate the need for occasional regional/global meetings within and across time zones.Key responsibilities (not limited to)
- Lead regional Regulatory Affairs function over the product lifecycle from pre-market concept, product development, registration, artwork and post-market advertising compliance and vigilance activities.
- Manage and support the Risk Management program and administer Risk identification, reduction, mitigation, escalation and reporting processes regionally.
- Support Regulatory Intelligence program regionally - identify, assess and communicate business impact to the Regulatory Affairs team and other internal stakeholders.
- Maintain regulatory compliance in line with business growth and regulatory strategy.
- Engage with regional regulatory authorities and industry groups to support Regulatory Risk and Intelligence programs
- Actively participate in regulatory/professional working groups to advocate on behalf of Aesop.
- Train regional senior stakeholders on regulatory matters including product compliance requirements, Cosmetovigilance, risk management.
- Manage regional Regulatory policy, procedures, position statements and regulatory compliance files.
- Report on regional KPIs.
- Manage and lead Continual Improvement Projects
- Deep technical expertise interpreting regional and global regulations (e.g., TGA listed medicines / therapeutic goods Act and Regulations including labelling and advertising codes, Permissible ingredient and indications lists, ASEAN Cosmetics Directive, Japan Cosmetic Regulations, Korea Cosmetic and Quasi Drug Regulations, Taiwan Cosmetic Regulation, EU/Middle East/Africa Cosmetic Regulations, Americas Regulations and MoCRA)
- Proven leadership experience in managing Regulatory Affairs team in a fast-paced environment
- Good understanding of Global Regulatory landscape
- Good understanding regional and Global regulatory requirements
- Knowledge of Cosmetics, Pharmaceuticals, and non-cosmetic regulations
- Proven ability to navigate ambiguity, manage stakeholders (locally and from countries where English is a second language)
- Fluency in language other than English could be advantageous (regionally relevant language highly desirable)
- Critical thinking and keen attention to detail
- Strong time management and organisational skills
- Flexible working arrangements (we value work-life balance)
- Flexible Fridays (summer hours)
- Generous product discount of up to 50% & complimentary product allocation
- Team lunches, sponsored social clubs, team events, and celebrations
- Parental leave and vaccination leave
- Individual training budget - strong focus on Learning and Development – access to the entire LinkedIn training library suite, and funded training programs
- Home office set-up reimbursements
- Short term incentive bonus programs to reward performance for applicable roles
- Access to Employee Assistance Program along with other wellbeing offerings including a complimentary Headspace subscription