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Regulatory Affairs and R&D Manager
4 weeks ago
Position overview
A newly created position, the Regulatory Affairs and R&D Manager will lead and support the Regulatory and NPD team to ensure product registration approvals and market access, enabling business growth through strategic regulatory planning and compliance.
Oversee regulatory evaluations, submissions, and stakeholder engagement while staying updated on legislative changes to drive efficient market entry and expansion.
Key Areas of Responsibility:
1. Manage and support the Regulatory and NPD team to achieve product registration approvals/market access opportunities to allow business growth.
2. Drive business partnerships with various divisions of the business.
3. Ensure creative and robust regulatory strategies are developed and delivered efficiently and in line with business needs.
4. Provide and oversee regulatory evaluation of new products, and/or existing product development (e.g. regulatory classifications) to enable efficient market access.
5. Manage 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.
6. Develop and maintain all products dossier compliance to regulatory requirements, including dossier management improvements and efficiencies.
7. Liaise with internal NPD project team to support their development and delivery of new products.
8. Use problem solving and collaboration to resolve any identified deficiencies or regulatory issues in a solutions-oriented manner, working closely with Scientific Affairs, Quality Assurance, Technical Services, and local brand teams.
9. Develop new products to capture market opportunities and increase BioMedica's market reach.
10. Support the development of regulatory policy priorities, company positions and stakeholder engagement plans.
11. Oversee and manage record keeping and documentation of all regulatory and scientific affairs matters, including documenting and following change control procedures.
12. Manage responses to correspondence received from the Australian regulatory authorities (e.g. TGA, FSANZ, etc) within an agreed priority and timeframe.
13. Maintain strong relationships with external agencies, suppliers or others.
14. Keep up-to-date with government legislation as it relates to regulatory affairs, with appropriate communication of (potential) impacts across the business.
15. Keep up to date with new raw material expansion, clinical research, ATRG listing.
About you:
The successful candidate will be a qualified naturopath or have equivalent experience with natural health medicines.
Key attributes that will support success in this role:
1. Self driven, results oriented with a positive outlook, and a clear focus on high quality outcomes.
2. Exceptional planning skills prioritising work requirements to meet deadlines in fast-paced marketing environment whilst maintaining a strong attention to detail.
3. Strong analytical and problem solving skills, excellent attention to detail and a commitment to compliance processes.
4. Ability to communicate cross-functionally with different departments with different levels of expertise.
5. Proven experience organising and motivating others.
6. Strategic thinker with a solutions-oriented approach.
7. Excellent understanding of at least two of the following areas: TGA OTC registered medicines, Listed medicines, Medical Devices, FSANZ regulatory requirements and guidelines.
8. 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 the TGA, Industry Associations and a broad range of internal stakeholders.
If you would like the opportunity to work for an innovative, industry leading company within a supportive team environment, submit your application via the button below. Please note, this is a full-time position, based at our head office in Alexandria, Sydney.
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