Scientific Affairs Associate Manager
5 months ago
**Introduction**:
About us
At PharmaCare, we inspire people to be the best, healthiest and happiest they can be. 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 are home to some of Australia’s most well-known and trusted brands including Nature’s Way, Bioglan, Sambucol, Norsca, Brut, Skin Doctors, Naturopathica, KP24, Aquasun, Promensil, BioMedica, Medlab and many more.
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.
We are family owned with a global reach, our products are found in pharmacies, supermarkets, department and variety stores all over the world.
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 health and salary continuance insurance
- Flexible working hours
- Secure onsite parking
- Employee assistance/wellbeing initiatives
- Ongoing training and development programs
- Leave loading
**Description**:
About the role
Reporting to the Senior Scientific Affairs Manager you will guide brand marketing teams from initial concept to successful product launch. You will work on-site at our Warriewood Head Office as a trusted partner in your area of expertise. You will provide technical advice, product development guidance, and regulatory experience to assist in the launch of compliant products, including; listed complementary medicines, assessed listed medicines, registered medicines, medical devices, foods and cosmetics. You will work closely with your science colleagues in Technical, Regulatory and Quality as well as relevant external stakeholders to ensure ideas successfully transition from concept to commercial reality.
Develop and deliver multiple product concept across assigned brands, categories and distribution channels efficiently and in line with company targets
Liaise with marketing on product concepts within brands
Sense-check concepts from marketing, and assist in defining concepts for efficient product development
Keep abreast of global and local product, formula and ingredient trends and contribute to the development of innovative NPD ideas in line with company focus.
Provide evidence-based formulations and innovative solutions to identified marketing concepts within regulatory requirements
Assist in making product development commercially viable and aligned with business initiatives to maximise return on investment (e.g. assess product viability - formulation, dosage forms, costs, batch size, etc)
Understand raw materials and be able to evaluate suitability for product development
Recommend permitted indications/therapeutic claims and marketing claims within regulatory requirements
Prepare indication and claim substantiation files that meet relevant regulatory requirements (e.g. TGA’s Evidence Guidelines for Listed Medicines, FSANZ, NICNAS, etc)
Maintain relationships with key external parties, including contract manufacturers, major suppliers, key customers and industry associations (as required)
Maintain adequate records and documentation of all scientific affairs related matters, collaborating as needed with regulatory affairs for dossier development, maintenance, and management
Ensure compliance of promotional material across various media platforms, including labelling and packaging, to appropriate regulations and legislation and advise/manage post-market advertising complaints and audits
- Drive multiple projects on different timelines to execute all required steps to move products through the Stage-Gate system
**Skills and Experiences**:
About you
You enjoy a fast-paced environment and have a passion for quality evidence-based products that support wellness outcomes for consumers.
Skills and experience that will support your success in this role:
3-5 Years experience in a complementary medicine, food and/or related product development, regulatory or scientific affairs environment
Naturopath, nutritionist, or other qualified health care professional with evidence-based medicine knowledge preferred
Exceptional organisational and planning skills with experience prioritising work requirements to meet deadlines in a fast-paced marketing environment whilst maintaining a high level of attention to detail
Project management experience, preferably working within Stage-Gate processes
Ability to communicate cross-functionally with different departments with different levels of expertise
Co-ordination and strong problem-solving ability
Demonstrated expertise in interpreting and critically analysing scientific research
Strong understanding of regulatory requirements and guidelines of the TGA
Experience with FSAN
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