IONELA V. FRUNZA

• Collaborated with cross-functional teams (Market Access, Clinical, Medical, Marketing, Quality Assurance, Legal and Compliance, Pharmacovigilance, Supply Chain Management, Finance) to ensure alignment on regulatory requirements and timelines.
• Enhanced regulatory compliance by developing and implementing effective policies and procedures.
• Fulfilled all regulatory needs for Module 1 Annexes (e.g. translations, proofreading, Vault RIM updates, EMA register updates monitoring) for all Novo Nordisk EMA approved products (i.e. Ozempic, Tresiba, Saxenda, Rybelsus, etc.)
• Recommended improvements to processes.
• Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
• Monitored competitor activities within industry landscape, informing strategic decision-making processes accordingly.
• Managed risk assessments and mitigations, resulting in reduction of potential compliance issues.
• Evaluated emerging local and european legislation and its potential impact on current products or future developments.
• Kept abreast of evolving industry trends, allowing the company to adapt quickly to changes in regulatory landscape (RAPS member).
• Spearheaded training initiatives for staff on regulatory affairs topics, promoting a culture of continuous learning.
• As appointed person responsible for regulatory compliance under MDR and IVDR, successfully navigated complex regulations for various types of medical devices (pen injectors, needles, etc) during their lifecycle stages and operating license maintenance.
• Negotiated favorable terms during interactions with regulators, fostering positive relationships that facilitated smoother approval processes for HCPs and patients educational materials.
• Provided responses to regulatory agencies regarding product information on stocks, marketing status, or other issues.
• Devised and deployed techniques for performing earliest possible notifications, consultancies and approvals from Health Authority
• Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.

Led cross-functional and cross-cultural teams in a global matrix environment, delivering R&D projects with a total NPV of over$100M, surpassing yearly KPIs by 30%.
• Led tri-weekly update calls with C-suite stakeholders and tracked R&D project progress using PLM Planisware. These updates directly influenced budget allocation, project prioritization, and cancellation decisions.
• Facilitated project kick-off meetings to align cross-functional teams on investment goals, budget expectations, and strategic outcomes.
• Performed variable cost analysis and contributed to Annual Operating Plans (AOP) and Long-Range Plans (LRP).
• Drafted Capital Expense Requests (CERs) up to $1M USD for C-suite approval, including financial justification and scenarios to support strategic investments.

• Streamlined internal processes, fostering improved efficiency and productivity within firm.
• Led strategic marketing functions (pre-sales and pre-production activities, study and choice of target market, pricing and distribution channels)

• Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
• Led execution and control processes by managing on time delivery of loyalty programs for top 100 corporate clients.
• Monitored project performance to identify areas of improvement and make adjustments.

• Analyzed customer feedback to identify areas for improvement in service delivery.
• Tracked customer and supply chain details for precise and timely fulfillment.

• Continuously updated knowledge of industry trends and advancements, ensuring ability to provide clients with most up-to-date product information and solutions.
• Regularly exceeded sales targets (30%, each quarter) by establishing rapport with new clients while maintaining long-lasting relationships with existing ones.
• Leveraged strong communication skills to present complex medical information in easily digestible manner for diverse audiences.
• Showcased product features to customers and discussed technical details to overcome objections and lock in sales.
• Participated in industry conferences and events, showcasing company products to wider audience of potential clients.
• Developed marketing materials such as case studies and product brochures to promote and educate buyers on product offerings.
• Worked closely with commercial operational departments to schedule targeted promotional campaigns.

• Established strong relationships with healthcare professionals, resulting in increased trust, credibility for the organization and targets surpassing by 28%.
• Analyzed market to identify new opportunities and strengthen relationships with hospitals, medical centres and primary provider physicians.
• Collaborated with sales team to implement targeted marketing strategies that boosted overall revenue growth.
• Managed territory OPEX efficiently and effectively prioritized visits to key healthcare providers and facilities.

• Performed analysis of pharmaceutical finished products ( in-process, release and stability), active ingredients and excipients using various analytical methods.
• Developed innovative analytical methods for finite products (HPLC – DAD/MWD), subsequent SOPs and submission dossier documentation, aiding in successful products registrations and launches.
• Collaborated with cross-functional teams to solve complex, industry-specific challenges in product development and manufacturing processes.
• Enhanced team productivity through effective tests scheduling and tasks prioritization.
• Contributed to cost-saving initiatives by identifying opportunities for more efficient use of resources within laboratory setting.
• Mentored junior chemists on best practices, contributing to their professional growth and success within the organization.
• Created spreadsheets and other forms of documentation to accurately record and calculate analytical results. Issued/signed various Quality Control documents such as Certificates of Analysis and SOPs.