Digital Platforms Manager – (FILLED/HIRED)

Reporting to the Chief Information Officer, the Digital Marketing Platforms Manager is responsible for the management and evolution of SFI Health’s global digital technology stack, to support marketing execution and business strategy.

This is an exciting opportunity for an entrepreneurial individual to drive transformation of our Australia business based out of Sydney.

Key Selling Points:

  • Based in St Leonards, with flexible work arrangements available
  • Enable stakeholders and businesses in Australia as well as overseas
  • Combine strategic thinking and long-term planning with hands on implementation and management
  • Work in a nimble, growth focused, purpose driven culture
  • Critical member of the Global Digital team you will be responsible for managing the roadmap of the digital platforms ensuring that the platforms keep pace with the needs of global user groups

What you’ll need to succeed

  • You will be an enthusiastic, driven collaborator who combines a results-oriented mindset with a supportive, positive, “can do” approach, who looks a lot like:
  • 5+ years’ experience managing digital marketing technologies and platforms
  • Experience implementing technology platforms and products, from establishing requirements, leading MVP definition, supplier contracting, governing the implementation and testing, creating support and maintenance processes and defining ongoing roadmaps
  • Global experience for multi-market use viewed favourably
  • In depth experience with a range of digital platforms
  • CMS, DAM, MAP and eCommerce platforms are essential
  • Experience with our suite of platforms (Mura / WordPress / Shopify / DotDigital / Welcome / AssetBank) would be viewed favourably
  • Experience with digital marketing training and education also viewed favourably, as would experience with DXP platforms
  • An understanding of cyber security fundamentals and how they should be applied to digital marketing platforms
  • Ability to derive actionable insights to improve digital effectiveness and performance based on data
  • Proven ability to deliver initiatives, through Scrum Master or project management experience
  • UX and design experience would also be viewed favourably, although is not essential

What you’ll get in return

This is a great time to join this rapidly expanding business.

You will have the opportunity to work in a diverse role in with a talented group of colleagues and stakeholders in Australia, Switzerland and the United States.

You will be able to make a difference, owning your goals and deliver on the promise of a purpose driven organisation.

If you are interested in this position, please send your CV to jobs@sfihealth.com.

Product Development Manager

SUMMARY:

As Manager of Product Development within Americas Region of SFI Health you will report and work closely with the Director of Product Design and Development in managing the PD team through formulating and product design for company wide projects to include; SFI Health brand, CMO/CDMO, and custom formula customers. A successful person in this role is confident, organized, and professional as this position will interact with heads of other departments and cross functional teams to achieve productivity goals.

This position is also responsible ensuring products is run effectively and efficiently on our manufacturing equipment by conducting bench work, production pilots and initiating change control process where applicable to improve formulations and process. We are seeking an A-player who doesn’t fear challenge but embraces it and will be at home in an environment where new approaches are welcomed and leadership in implementing them well is rewarded. 

JOB FUNCTIONS:

Essential job functions: Plan, manage, and engage team to deliver on major and minor projects with significant commercial implications by keeping stakeholders informed, engaged and on time

Product Development and Formulation Management:

  • Contribute to oral dosage formulation and process development, process scale up and technology transfer to commercialization throughout the product lifecycle.
  • Develop, Design and/or Review Master Formulas, Product Specifications ensuring accuracy and is compliant with Regulatory, SOP, SAP, and customer requirements.
  • Evaluate the formulation and process to determine their effects in relation to final product specification, including evaluating equipment set points and process parameters for their impacts on final product characteristics.
  • Design, plan and execute prototype formulation development studies, and scale up of manufacturing processes.
  • Identify and execute projects to reduce product cost, improve product quality, improve yield, and reduce material usage, and collaborate with Production, Engineering, and Quality to optimize productivity, yield, product quality, and supply reliability.
  • Provide support to ensure Inspections, Deviations, Change Control, CAPAs and Regulatory commitments are met on time with the highest standards of quality.
  • Establish and upgrade programs, practices, and processes to drive a high-performance culture and engaged workforce across Safety, Quality, Delivery and Cost.
  • Lead project teams in developing project strategy for both new product development and tech transfers, including process validation, and associated regulatory filings as required.
  • Collaborate with cross functional and cross organizational partners, both on site and off site to establish project plan timeline with appropriate milestones.
  • Provide process technology training, SOP writing, technical reports and Validations, as well as providing training and support to Product Development personnel during the development and scale up of formulations on cGMP equipment.
  • Must stay current with relevant technologies and forward thinking to identify new approaches.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education:

  • A minimum of BS degree in Pharmaceutical Science, Pharmaceutics, Pharmacy, Industrial Physical Pharmacy, Chemistry, Pharmaceutical Engineering, Chemical Engineering, Biology, Chemistry, Nutrition or an equivalent foreign degree.
  • Experience with Quality management systems, SAP software project management software desired, Quality by Design

Experience:

  • A minimum of 8 years of experience for BS or 6 years of experience for MS in Solid dosage formulation and/or pharmaceutical/ nutraceutical manufacturing areas.

Technical/Functional Skills:

  • Must be proficient and have hands on experience with manufacturing processes such as blending, encapsulation, compression, milling, roller compaction, tablet coating and other related solid dosage form manufacturing unit operations.
  • Ability and eagerness to learn new manufacturing technologies.
  • Good understanding on quality and regulatory requirements of nutraceutical and/or pharmaceutical industry.
  • Ability to train fellow scientists, lead project teams on new product development and technology transfer activities.
  • Serves as an effective subject matter expert to cross-functional teams

Computer skills:

  • Microsoft Office Suite and analytic tools
  • Document and Change Control, Qualityze or other EQMS
  • Database management
  • Total Quality Management

OTHER INFORMATION

Supervisory Responsibilities:

This position supervises the following positions:

  • Product Development Specialist – I and II
  • Product Development Scientist – I and II

Work Environment: On site at Reno, NV offices

Physical Demands: Working outside of normal business hours when keeping the project running smoothly requires it.

Career Path (Optional):  Opportunity for growth into Sr. Director or VP at the regional or potentially global level

Who to Contact:

Send your applications to: humanresources.us@sfihealth.com

Regulatory Affairs Manager- ASIA (FILLED/HIRED)

Your new company:

At Soho Flordis International (SFI Health), we believe we have the responsibility to bring proven natural health solutions to people’s healthcare needs. We are a global natural health company committed to sourcing and producing natural medicines to the highest standards. Backed by evidence of effectiveness, quality and safety, our products are marketed around the world using our international community of leading life sciences companies and distributor networks.

You will join the business at a time of significant positive change and be able to directly contribute to the strategic goals.

Your new role:

  • This role is to execute and maintain regulatory strategies for Key products in order to obtain/maintain regulatory approvals and regulatory compliance in target markets in line with Business strategies.
  • Strategic Lead representing regulatory expertise while developing new approaches for business objectives, applies knowledge and understanding of the regulatory framework, legislations, and processes to maintain a product on the market, reporting and surveillance. Responsible for business regulatory activities (CTDs, eTSF), regional maintenance/compliance project management, and business regulatory assessment on all products with active status

Key Responsibilities in the role:

  • Execute and maintain regulatory strategies (including appropriate classification per country) for key product submissions in order to obtain/maintain regulatory authority approvals in line with business plans and needs including managing the global registration project, co-ordinating inputs, meeting milestones, identifying risks to timing and mitigating strategies, communicating with regional regulatory, global and regional/local sales and marketing regarding timings
  • Support the strategy of SFI Health Asia  in order to secure better global harmonisation of natural medicine regulation, both internally and externally
  • Coordinate and compile data and documentation to provide a data package or dossier compliant to requirements of regulatory authorities in Asia.

What you’ll need to succeed:

The ideal candidate for this position will have understanding of Natural medicines with several years of Regulatory Affairs experience preferably in complementary medicines  and/ or over the counter medicines (OTC) and dietary supplements in the Asia region.

  • Strategy – Able to apply knowledge of regulatory Frameworks and external environments, throughout the product lifecycle.
    • Determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
    • Identifies relevant laws, regulations, and guidance source documents for local, regional, and global regulations.
    • collects organises and maintains files on local, regional, and global regulatory intelligence, monitoring the regulatory environment.
    • Research requirements and options for regulatory submissions, approval pathways and compliance activities.
    • Assists in the development of regulatory procedures and SOPS.
    • Collect data relevant to regulatory questions, issues, or problems.
  • Business Acumen – Leverage systems and processes to successfully operate a regulatory function.
    • Frames issues with a thorough understanding of regulations, guidance, policy, and directives.
    • Ensures alignment of regulatory information management systems with other organisational systems.
    • Reviews change controls to determine level of change and consequent submission requirements.
    • Works with cross functional teams to provide regulatory input and technical guidance on regulatory requirements for product regulatory filings.
    • Ensure compliance with relevant quality standards. Frames issues with a thorough understanding of regulations, guidance, policy, and directives.
    • Understand the role of regulatory authorities, regulated industries and regulatory professionals and their interrelationships with other stakeholders.
    • Preserve confidentiality of product information as appropriate.
    • Track staging of activities and milestones in regulatory work plans.
    • Understands/tracks scientific and health principles and advances related to product development and regulations.
  • Communication – Ability to clearly convey or exchange information with stakeholders including team members within and parties outside the organisation.
    • Communicates with peers and team members to ensure alignment in issues, questions, and goals for completion of project tasks.
    • Shares and provides open access to information at all times and genuinely listens to the ideas of others.
    • Clearly conveys information to internal and external stakeholders in an appropriate and timely manner.
    • Co-author basic regulatory documents and reports.
    • Communicate information on regulatory requirements to other functions.
    • Assists in preparation for meetings and briefings with stakeholders.
    • Clearly conveys information to peers and other stakeholders.
  • Leadership – Ability to direct and contribute to initiatives within the organisation
    • Connects with diverse people to seek out diverse ideas, opinions, and insights to apply in the workplace.
    • Demonstrates ethical behaviour by ensuring integrity in work practices, respects people and principles, including professional, ethical and people values.
    • Accountable for own behaviours and actions. Takes responsibility for errors, acknowledging opportunities for improvement, pursuing new ideas and perspectives, and applying learning.
    • Demonstrates the importance of working together in the spirit of openness, honesty, and transparency that encourages engagement, collaboration, respectful interactions, and trust.
    • Prioritises work to meet timelines.
  • Technical – application of knowledge of regulatory requirements for all aspects of the product lifecycle and healthcare landscape in which the regulations sit.
    • Prepares and submits regulatory submissions and technical reports according to applicable regulatory requirements and guidelines with limited oversight.
    • Provides regulatory information and guidance for proposed product claims / labelling
    • Prepares and submits regulatory submissions and technical reports according to applicable regulatory requirements and guidelines with limited oversight. Complete low risk regulatory assignments under appropriate supervision.
    • Assures post market regulatory requirements are met, including submission of notifiable changes and supplemental dossiers. Assists in preparation of dossiers and submission packages for regulatory agencies.
    • Track status of applications under review and provides updates.
    • Collects and organises information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
    • Assists in the review of product collateral/claims.

Qualifications & Experience

  • Understanding of natural medicines
  • 5 years + of Regulatory Affairs experience in complementary medicines and dietary supplements

Job Skills

  • Flexible with working hours
  • Able to work with minimal supervision.
  • Excellent communication (verbal and written skills).
  • Ability to organise and motivate others.
  • Good strategic thinker and project management.
  • Good attention to detail.

Relationships 

  • Close collaboration with Regional Regulatory and Global Regulatory Manager
  • Industry Associations.
  • Close cooperation with Global R&D, Research, Medical Affairs, Marketing teams.
  • Regional M&S and Project Management teams

Personality

  • Self-driven, results-oriented with a positive outlook, a clear focus on high quality outcomes and strong attention to detail
  • A natural forward planner who critically assesses own performance and works with others to deliver to timelines
  • Mature, credible, and comfortable in dealing with key stakeholders
  • Reliable, tolerant, disciplined and determined
  • A passion for clinically proven natural medicines
  • Empathic communicator, able to see things from the other person’s point of view
  • Well-presented and businesslike
  • Tolerant, able to get on with others and be a team-player.

Business Skills:

  • Strong commercial focus and ability to solve regulatory challenges in commercial situations
  • Able to work effectively with multiple internal and external stakeholders, being mindful of SFI business profitability requirements

What you’ll get in return:

This is an exceptionally good time to join this rapidly expanding business with an ambitious roadmap. You’ll be given the opportunity to make a meaningful impact on how we do things.

  • Awarded CMA Complementary Medicines Australia’s Judges Choice Award 2021 & 2022
  • Opportunity to make a difference in a purpose led  Values driven organisation

We pride ourselves by attracting talent who bring integrity, courage and passion to what we do. If you believe that your strengths and ambitions are aligned, please apply today!

Sounds like you:

If you are interested in this position, please send your CV to jobs@sfihealth.com