Regulatory Affairs Associate

**Introduction**:
About us
At PharmaCare, we inspire people to be the best, healthiest and happiest they can be. As an Australian born and built success story we are proud of our heritage and remain a 100% Australian owned and family operated business. We are home to some of Australia’s most well-known and trusted brands including Nature’s Way, Bioglan, Sambucol, Norsca, Brut, Skin Doctors, Naturopathica, KP24, Promensil, BioMedica, Medlab and many more.
Our success comes from our performance led culture, and we want our people to succeed. We encourage ownership and integrity with an entrepreneurial flair. Based on the Northern Beaches we live the life we promote.
We are family owned with a global reach, our products are found in pharmacies, supermarkets, department and variety stores all over the world.
Extras we know you’ll love
- On site 3 level gym with dedicated personal trainers and daily classes
- Full time barista with free coffee and free smoothies
- Generous monthly product allowance to support your health and wellbeing
- Paid parental leave, subsidised health and salary continuance insurance
- Flexible working hours
- Secure onsite parking
- Employee assistance/wellbeing initiatives
- Ongoing training and development programs
- Leave loading
- A supportive, fun and collaborative working environment

**Description**:
About the role
As part of the Regulatory Affairs team, this role is primarily responsible for supporting product compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products in Australia and Asian markets. This includes strategic regulatory advice, preparing, submitting and tracking regulatory submissions, and maintaining compliance for product portfolios in a solutions-oriented manner in line with business strategies and priorities.
**The main responsibilities will include**:

- Implementing agreed regulatory strategies efficiently and in line with business needs
- Provide regulatory support and recommendations for the assessment and market access of new products, and/or existing product development (e.g. regulatory classifications
- Review and maintain documentation in the dossier compliant to regulatory requirements
- Identify deficiencies in product dossiers (involving problem-solving and collaboration) to resolve any identified deficiencies in a solutions-oriented manner
- Liaise with external agencies, suppliers or others to ensure compliant product dossiers and facilitate evaluation
- Maintain adequate records and documentation of all regulatory and scientific affairs matters, including documenting and following change control procedures
- Ensure compliance of labelling and packaging to appropriate regulations and legislation
- Responsibility for the maintenance of databases related to regulatory activities (eg. data entry, filing of regulatory correspondence, artwork (pack) management)
- Ensure compliance with all systems and processes
- Working closely with local brand teams, Scientific Affairs, Quality Assurance and Technical Services to manage responses to correspondence received from the Australian and or Asian regulatory authoritites and consultants (e.g. TGA, FSANZ, etc) within an agreed priority and timeframe.
- Contribute and assist in responding to post-market product assessments and audits from government agencies and regulators
- Keep up to date with government legislation as it relates to regulatory affairs
- Provide support for submissions to government regulatory consultations and reforms

**Skills and Experiences**:
About you
- A science-based degree or postgraduate qualification
- Self-driven, results oriented with a positive outlook, and a clear focus on high quality outcomes
- Able to work with mínimal supervision with exceptional planning skills prioritising work requirements to meet deadlines in a fast-paced marketing environment whilst maintaining a strong attention to detail
- Strong analytical and problem-solving skills
- A commitment to compliance