About us
PharmaCare Laboratories is a dynamic Australian owned company, that operate and sell an impressive range of well-known and respected brands throughout pharmacy and grocery channels within Australia and overseas. We are dedicated to enriching people's lives through improved health and wellness. Our success comes from our performance led culture, and we want our people to succeed. We encourage ownership and integrity with an entrepreneurial flair.
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
About you
Ideally you will 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
