Anna Noiman
Boronia,VIC
Summary
Self-motivated Regulatory Affairs Associate holding over three years of pharmaceutical industry work experience. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory leadership for new product development and change management activities. Passionate about innovation and ground breaking biomedical and pharmaceutical products that are set to make a difference.
Overview
11
11
years of professional experience
1
1
Certification
Work History
REGULATORY MANAGEMENT AND TRADE COMPLIANCE SPECIALIST
Merck Life Sciences
11.2023 - Current
- Manage documentation and record-keeping for all international transactions conducted within the company.
- Upheld proper classification of products according to tariff codes
- Oversaw daily operations of a busy office environment, ensuring tasks were completed efficiently and accurately.
- Conduct risk assessments to identify potential compliance issues and develop strategies to mitigate risks
- Collaborate with other departments to assess the impact of regulatory changes on business operations and developed strategies and solutions for areas requiring mitigation.
- Obtain and manage the necessary licenses and permits for import and export activities world-wide
- Work with regulatory agencies to ensure all required authorizations are obtained and remain within the legal expectations for the company.
- Maintain accurate and up-to-date documentation related to regulatory and compliance activities
- Uphold ethical standards in all compliance activities and decision making.
- Reduced costs by identifying inefficiencies in operations and implementing cost-saving measures.
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Optimized supply chain management, resulting in reduced delivery times and increased inventory accuracy.
- Followed all company policies and procedures to deliver quality work.
- Listened and responded to customer requests and forwarded necessary information to superiors.
- Assisted with staff training to enforce quality, safety and sanitation guidelines.
- Maintained current understanding of market conditions, compliance standards and best practices.
- Attended training programs to deepen professional skillset and assisted in training fellow associates on existing and new training programs.
REGULATORY AFFAIRS ASSOCIATE
Firebrick Pharma Ltd.
11.2020 - 11.2023
- Direct experience in registered and listed OTC medicines and medical devices through Australia, New Zealand, Europe and Asia.
- Enhanced regulatory compliance by meticulously reviewing and editing submission documents including product dossiers, technical files, labellin and packaging, and risk assessments, under standard operating procedures (SOPs) and harmonized regulatory guidelines
- Collaborated with cross-functional teams, including R&D, quality assurance, clinical affairs, and marketing, and provided regulatory input and support throughout product development.
- Assisted in developing regulatory strategies for new product registrations, line extensions, and product lifecycle management, considering commercial objectives, timelines, and risk mitigation.
- Provided regulatory guidance to internal stakeholders to enhance understanding of regulatory processes and requirements.
- Analysed stability and manufacturing data from manufacturers to ensure Certificates of Analysis and Certificates of Origin were compliant with the objectives of products.
- Supported the company through a Section 60 Appeal and Administrative Appeals Tribunal (AAT) with the TGA
- Enhanced the company literature collection by creating a library of publications and clinical trials based on Pharmacovigilance expectations and for R&D principles relating to products and areas of interest.
- Sought training for the creation of the company's Quality Management Systems and standard operating procedures (SOP), and applying skills to continue developing and maintaining quality assured principles.
- Collaborated with cross-functional teams for timely and accurate submissions of new drug applications.
- Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.
- Assisted in developing effective strategies for addressing regulatory inquiries, leading to faster resolution times.
- Monitored industry trends and regulatory updates, maintaining a strong understanding of current best practices in the field.
- Provided guidance to team members on regulatory requirements, promoting a culture of compliance within the organization.
- Conducted risk assessments to identify potential areas of non-compliance, implementing corrective actions as needed.
- Supported global product registrations by liaising with international partners and assisting with local regulatory requirements.
- Developed training materials for new hires, facilitating knowledge transfer and enhancing overall team competency in regulatory affairs.
- Created a centralized repository for key regulatory documents, improving accessibility and reducing document redundancy across departments.
- Prepared comprehensive reports on the status of ongoing regulatory projects for management review and decision-making purposes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Assisted with regulatory product compliance initiatives such as Nasodine Nasal Spray and Nasodine Throat Gargle.
- Recommended improvements to processes.
- Consolidated global information relevant to Nasodine Nasal Spray and monitored global submissions and approvals status.
- Conducted thorough reviews of labelling content for accuracy and adherence to relevant regulations before submission to authorities.
LABORATORY ASSISTANT - MOLECULAR PCR
Dorevitch Pathology
06.2020 - 07.2021
- Samples handling of microbiologic, respiratory swabs, urine, and blood samples, and applying these to assays for analysis
- Proficient in skills using ULTRA, PWL, and Microsoft office applications
- Maintaining professionalism with senior representatives of company
- Conducting PCR testing and excelling in accurate and timely pipetting
- Preparation and cleaning of machines such as BGI6800, MGISP-3000 and MGISTP-7000
- Led team in effective cleaning and discarding of contaminated and biohazardous waste with understanding of all safety precautions
- Contributed to storing patient information for archives and sending final sample documents for reporting to the DHHS
- Reduced sample contamination risks through rigorous adherence to proper specimen handling techniques.
- Supported scientific investigations by preparing necessary reagents, solutions, and materials for various experiments.
- Trained new laboratory personnel on standard operating procedures, ensuring consistent performance across team members.
- Increased accuracy of experiment results by calibrating instruments regularly and troubleshooting equipment issues promptly.
- Managed inventory levels effectively by tracking supply usage and placing orders for required materials before depletion.
- Maintained documentation on tests performed in lab.
RETAIL ASSISTANT AND ECOMMERCE REPRESENTATIVE
Anaconda Stores
03.2018 - 02.2021
- Facilitated and led team training and information sessions in ecommerce practices
- Coordinating online customer orders/ business orders, communication with executive members of ecommerce sector and Spotlight Retail Group leaders
- Handling hundreds of customer orders daily, preparing online orders for same day dispatch
- Outstanding product knowledge, experience and education, as well as adopting company values and culture.
- Boosted customer satisfaction by providing exceptional service and addressing inquiries efficiently.
- Enhanced store appearance through diligent merchandising and regular upkeep of displays.
- Managed inventory with accuracy, ensuring optimal product levels and minimizing stock discrepancies.
- Collaborated with team members to accomplish sales goals and improve overall store performance.
- Resolved customer complaints professionally, maintaining a positive brand image.
- Implemented strategic promotional efforts for increased revenue and foot traffic in the store.
- Participated in seasonal sales events and promotions, maximizing their impact on revenue generation.
- Used POS system to process sales, returns, online orders, and gift card activations.
- Worked closely with shift manager to solve problems and handle customer concerns.
REGULATORY AFFAIRS ASSISTANT
Pharmreg (Aust) Pty Ltd
05.2020 - 09.2020
- Conducted 80-hour placement completion (remotely)
- Developed an overall understanding and respect for the regulation of Therapeutic Goods in Australia and overseas, and identified how the topics studied in the Biomedical Science degree can be applied to the Regulatory Affairs role
- Adopting values and mindset of the TGA in order to compile and present adequate research and dossiers for clients
- A practical application of information learned, to writing Australian Product Information and Consumer Medicine Information in patient friendly language
- An expansion of IT skills in their application to the structured documentation requirements for dossiers submitted to health authorities for approval (Common Technical Document- CTD)
- Understanding the principles guiding the decision of regulators for therapeutic goods include prescription, over the counter and complementary medicines, blood products and also devices
- Understanding then principles behind the supply of unlicensed product in Australia (Special Access Scheme)
- Insight into some of the roles of the World Health Organisation, and specifically the Essential Medicines List and developing countries.
HOSPITALITY
Sentosa Noodle & Rice/Market House 105/Wild grains Bake House
01.2015 - 01.2017
- Delegating exceptional customer service, maintaining friendly and memorable service and connections
- Approached with accuracy in cash handling, eftpos functioning, refund transfers and end of day banking
- Executed exceptional stock replenishment, cleaning areas of work and maintaining environment hygiene
- Specialized food and beverage (barista, sandwich bar) handling.
WORK EXPERIENCE STUDENT
Austin Hospital
06.2013 - 06.2013
- Expanded curriculum offerings through volunteering, developing new industry experience based on career progression interests.
- Gained field exposure to medicine and nursing through observation in emergency department of the Austin Hospital.
- Developed an appreciation and passion for medicine and healthcare which has propelled career aspirations.
- Daily rotation of different wings of the ED, shadowing nurses on their treatment of patients.
- Hands-on experience contributing to in patient care such as taking blood pressure, providing social engagement with the patients, recording and taking notes of patient condition.
- Strengthened connections between theory and real-world application by asking questions and having conversations with field professionals.
Education
Bachelor of Biomedical Science - Medical Biotechnology
DEAKIN UNIVERSITY
Burwood, VIC11.2020
Victorian Certificate of Education -
MOUNT LILYDALE MERCY COLLEGE
Lilydale, VIC11.2016
Skills
- Regulatory Compliance
- Quality Assurance
- Emergency Response
- Customer Relations
- Documentation Management
- Industry knowledge
- Cross-functional collaboration
- Attention to detail
- Data analysis
- Training and development
- Project Restructuring
- Good Clinical Practices
- Regulatory Research
- Good Manufacturing Practices
- Trial Data Handling
- Regulatory Submissions
Accomplishments
- Obtained relationship in [holistic] mentorship and leadership.
- Participate in impactful coaching cantered around all aspects of growing and developing in personal, professional, social, and public settings and relationships.
- Public speaking courses
- Following one year as a team member, was promoted to Ecommerce representative Anaconda Bayswater (2019-2021)
- Employee of month June recipient Anaconda (2019)
Additional Information
- Member of Association of Regulatory and Clinical Scientists (ARCS) to the Australian Pharmaceutical Industry since 2020
- Attendee of ARCS conference Sydney (2023)
- Member of Consumer Healthcare Products (CHP) Australia since 2020
volunteer experience
- Australian Red Cross Blood donor
- Volunteering retail skills to Mustard Tree Op Shop (2017-2018)
- St Vincent De Paul Winter Soup Van (Melbourne CBD) 2016
project experience
Project management experience through several group projects and event coordinating (University)
language skills
Fluent speaking Russian
organizations
- Member of Deakin University's Student Association (DUSA)
- Deakin University Biomedical Society (DUBS)
relative skills
- Assess and critique clinical and non-clinical data.
- Strong knowledge of local regulatory and compliance requirements, guidelines, and processes.
- Understanding and familiarity with regulatory frameworks in key markets around the world.
- Excellent written and verbal communication skills, with the ability to effectively interact with internal and external stakeholders.
- Detail-oriented with exceptional organizational skills to manage multiple projects, tasks, and priorities simultaneously.
- Deep understanding of how regulatory strategies align with business objectives
- Proficient in using regulatory information systems and resources, document management, and other relevant software tools such as SAP.
- Have experience with research and product development based on regulatory expectation and manufacturing and analysis standards.
- Knowledge of quality management systems, standard operating procedures, international organization of standardization (ISO), good manufacturing practices, and harmonized regulatory expectations.
- Strong problem solving and analytical skills to assess and address regulatory challenges.
- Logical thinker, coachable and an open communicator.
Languages
Russian
Native or Bilingual
Certification
· Member of Association of Regulatory and Clinical Scientists (ARCS) to the Australian Pharmaceutical Industry since 2020
· Attendee of ARCS conference Sydney (2023)
· Member of Consumer Healthcare Products (CHP) Australia since 2020
Affiliations
- Exercise and Health Care
- Painting
- Community Service and Volunteering
- Outdoor Acitivities
Timeline
REGULATORY MANAGEMENT AND TRADE COMPLIANCE SPECIALIST
Merck Life Sciences
11.2023 - Current
REGULATORY AFFAIRS ASSOCIATE
Firebrick Pharma Ltd.
11.2020 - 11.2023
LABORATORY ASSISTANT - MOLECULAR PCR
Dorevitch Pathology
06.2020 - 07.2021
REGULATORY AFFAIRS ASSISTANT
Pharmreg (Aust) Pty Ltd
05.2020 - 09.2020
RETAIL ASSISTANT AND ECOMMERCE REPRESENTATIVE
Anaconda Stores
03.2018 - 02.2021
HOSPITALITY
Sentosa Noodle & Rice/Market House 105/Wild grains Bake House
01.2015 - 01.2017
WORK EXPERIENCE STUDENT
Austin Hospital
06.2013 - 06.2013
Bachelor of Biomedical Science - Medical Biotechnology
DEAKIN UNIVERSITY
Victorian Certificate of Education -
MOUNT LILYDALE MERCY COLLEGE
· Member of Association of Regulatory and Clinical Scientists (ARCS) to the Australian Pharmaceutical Industry since 2020
· Attendee of ARCS conference Sydney (2023)
· Member of Consumer Healthcare Products (CHP) Australia since 2020
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