Regulatory Affairs Associate

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Introduction:
About us

At PharmaCare, we are dedicated to enriching people's lives through improved health and wellness. 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 have built on our success at home and now have sales and marketing operations around the globe, where we sell and market our well-known and trusted brands.

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.

This is more than a job, it’s a chance to be part of something bigger. At PharmaCare, your career can grow alongside brands that are trusted by millions.

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. This includes preparing, submitting and tracking regulatory submissions, and maintaining compliance for product portfolios.

Indicative duties 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)
Preparation, submission and tracking of regulatory applications for a defined product portfolio of listed complementary medicines, registered medicines, medical devices, foods, cosmetics, and other FMCG products
Review and maintain documentation in dossier compliant to regulatory requirements
Identify deficiencies in product dossiers (involving problem solving and collaboration) to resolve any identified deficiencies
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 regulatory authorities (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

Skills and Experiences:
About you

• Self-driven, results-oriented with a positive outlook, and a clear focus on high quality outcomes
• Able to work with minimal supervision with exceptional planning skills prioritising work requirements to meet deadlines in fast-paced marketing environment whilst maintaining a strong attention to detail
• Strong analytical and problem solving skills, excellent attention to detail and a commitment for compliance processes
• Good written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA, Industry Associations and a broad range of internal stakeholders.