Regulatory Affairs Associate Manager

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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.

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 private health insurance
• Salary continuance and TPD insurances fully paid
• Flexible start and finish times
• Onsite parking
• Employee assistance/wellbeing initiatives
• Ongoing training and development programs
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Description:
About the role

As part of the Regulatory Affairs team, this role is primarily for supporting product compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products across the Asia Pacific markets. This includes strategic regulatory advice, preparing, submitting and tracking regulatory submissions, and maintaining compliance for product portfolios in a solutions-orientate manner in line with business strategies and priorities.

You will ensure that the company’s products adhere to the standards set by any applicable regulatory bodies, whilst providing support to facilitate export of products, compliant products and claims substantiation.

This is a people leader role, leading, managing and developing an RA team to product a high achieving and dynamic RA team

The main responsibilities will include:
Manage and support the Regulatory team to achieve product registration approvals/market access opportunities to allow business growth
Drive business partnerships with various divisions of the business
Ensure creative and robust regulatory strategies are developed and delivered efficiently and in line with business needs
Manage preparation, submission and tracking of regulatory applications
Develop and maintain all products dossier compliance to regulatory requirements, including dossier management improvements and efficiencies
Use problem solving and collaboration to resolve any identified deficiencies or regulatory issues in a solutions-oriented manner, working closely with other stakeholders
Develop new regulatory processes and provide process improvement advice to improve RA compliance and efficiency, and concomitant business ramifications in conjunction with the Senior Regulatory Operations Manager
Support the development of regulatory policy priorities, company positions and stakeholder engagement plans
Oversee and manage record keeping and documentation of all regulatory matters, including documenting and following change control procedures
Manage responses to correspondence received from regulatory authorities within an agreed priority and timeframe
Maintain strong relationships with external agencies, consultants, suppliers or others
Keep up-to-date with government legislation as it relates to regulatory affairs, with appropriate communication of (potential) impacts across the business
Provide expert advice and contribute to submissions to government regulatory consultations and reforms in line with business objectives
Draft safety data sheets and PIF’s as needed
Claims support for the marketing teams as needed
Drive multiple projects on different timelines to execute all required steps to move products through to launch

Full-time on-site role based in Warriewood on Sydney's Northern Beaches.

Skills and Experiences:
About you

Ideally you hold a science-based degree or post graduate qualification and will have experience and subject matter expertise in the Asia Pacific regulatory affairs.

• Self-driven, results oriented with a positive outlook, and a clear focus on high quality outcomes
• 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
• Ability to communicate cross-functionally with different departments with different levels of expertise
• Proven experience organising and motivating others
• Strategic thinker with a solutions-oriented approach
• Broad understanding of regulatory requirements across Asia Pacific region
• Excellent written and verbal communication skills with the ability to be persuasive and foster positive and credible relationships with a broad range of stakeholders including regulators, industry associations and abroad range of internal stakeholders