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