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Regulatory Affairs and R&D Manager

BioMedica • FULL_TIME • Alexandria, NSW, AU • 2w ago

Regulatory Affairs and R&D Manager

About us

BioMedica is a natural health company dedicated exclusively to the needs of practitioners in clinical practice. Founded by naturopaths, BioMedica has created a product range and support structure to exclusively serve the needs of the professional holistic practitioner. Based in Alexandria, we are a close-knit team passionate about the importance of quality wellness products and education.

BioMedica is a wholly owned company within the PharmaCare Group, an Australian owned and operated wellness organisation - for more information, please see www.biomedica.com.au

Job Description

About the role

Manage and support the Regulatory and NPD 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
Provide and oversee regulatory evaluation of new products, and/or existing product development (e.g. regulatory classifications) to enable efficient market access
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
Develop and maintain all products dossier compliance to regulatory requirements, including dossier management improvements and efficiencies
Liaise with internal NPD project team to support their development and delivery of new products
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
Develop new products to capture market opportunities and increase BioMedica’s market reach
Support the development of regulatory policy priorities, company positions and stakeholder engagement plans
Oversee and manage record keeping and documentation of all regulatory and scientific affairs matters, including documenting and following change control procedures
Manage responses to correspondence received from the Australian regulatory authorities (e.g. TGA, FSANZ, etc) within an agreed priority and timeframe
Maintain strong relationships with external agencies, 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
Keep up to date with new raw material expansion, clinical research, ATRG listing.

Desired Skills and Experience

About you

You are a qualified naturopath or have equivelant experience with natural health medicines.

Attributes that will support success in this role:

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 to 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
Excellent understanding of at least two of the following areas: TGA OTC registered medicines, Listed medicines), Medical Devices, FSANZ regulatory requirements and guidelines
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