IONELA FRUNZA
Pharmaceutical Industry
Bucharest
Summary
Focused and forward-thinking chemist working for more than 15 years in top pharma-biotech companies, who gets things done (eventually).
Intuitive and witty, dislikes superficiality or pretense.
Holds a vast industry knowledge, as is equally experienced in Regulatory Affairs, R&D Project Management, Sales and Quality Control. Performance-driven but ethical, uses critical thinking to transform complex ideas into tangible results and to increase revenue.
Very skilled at representing a department in internal and external meetings and to efficiently interact with key stakeholders. With a proven track record of surpassing targets and KPIs, does very good at networking, motivating, and influencing teams.
Currently, diligent Regulatory Affairs Managers with 3.5 years of supporting compliance management experience. Works well with consulting cross-functional teams on minimizing regulatory risk. Goes above and beyond to manage priorities and problem-solve with quick turn-around expectation.
Overview
22
22
years of professional experience
Work History
Regulatory Affairs Manager
Novo Nordisk
02.2021 - Current
- 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.
Project Manager Global R&D - Sterile Injectables
Teva Pharmaceuticals
01.2018 - 01.2020
- Successfully managed multiple (30) large project worth $100M in NPV (R&D of generic sterile injectable drugs - pre-submission & pre-approval phase - for 7 manufacturing sites and 4 global markets (US, EU, BR, JP).
- Prepared detailed, periodical (every 3 weeks) updates on project status for C-suite executives, ensuring transparency and cross-functional alignment with objectives.
- Planned, designed, tracked and scheduled phases for projects in PLM (Planisware) and subsequent business intelligence tools.
- Identified plans and resources required to meet project goals and objectives, ultimately drafting R&D business cases an subsequent project development budgets.
- Ensured accurate and timely Annual Operating Plans (AOP) ans Long Range Plans (LRP).
- Monitored project performance to identify areas of improvement and make adjustments.
- Monitored progress against established goals, adjusting schedules and resources as needed to deliver on time, on budget and on scope.
- Supported New Product Introduction and New Product Planning departments.
- Led transfers of knowledge from R&D to Operations.
- Drafted and submitted for approval CERs (Capital Expense Requests) (value of >$1B).
- Supported project-subsequent Regulatory Affairs global teams to ensure right first-time (RFT) file submissions and approvals by FDA, EMA, ANVISA, PMDA.
Partner
Family Business Venture
08.2012 - 05.2017
- 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)
Project Manager Corporate Clients
Regina Maria
11.2010 - 04.2011
- 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.
Medical Representative Cardiology & Anticoagulants
Egis Pharmaceuticals
06.2009 - 06.2010
- Analyzed customer feedback to identify areas for improvement in service delivery.
- Tracked customer and supply chain details for precise and timely fulfillment.
Medical Representative Diabetes & Cialis
Eli Lilly
06.2007 - 02.2009
- 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.
Medical Representative
Berlin-Chemie (Menarini)
11.2005 - 05.2007
- 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.
Research & Development Analytical Chemist
Alvogen
02.2002 - 11.2005
- 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.
Education
Master of Science - Quality Control of The Environment
University of Bucharest
Bucharest, Romania 04.2001 -
Bachelor of Science - Chemistry (French Language)
University of Bucharest
Bucharest, Romania 04.2001 -
Certificate Business - "Managing The Company of The Future"
London Business School (coursera.org)
Online 04.2001 -
Certificate Intellectual Property - "Protecting Innovations Via Trademarks & Patents"
HKUST (coursera.org)
Online 04.2001 -
Language Proficiency Certificate - French Language
Embassy of France in Bucharest
Bucharest, Romania 04.2001 -
Certificate in Advanced English (CAE) - Council of Europe Level C1
University of Cambridge & British Council
Bucharest, Romania 04.2001 -
Certificate - Professional Negotiation Techniques
Miller Heiman Group (Achieve Global)
Bucharest, Romania 04.2001 -
Certificate - Self & Situational Leadership
Ken Blanchard & Eli Lilly
Bucharest, Romania 04.2001 -
Skills
Pharmaceutical Industry
Languages
Romanian
Native language
English
Proficient
C2
French
Proficient
C2
Spanish
Upper intermediate
B2
Italian
Upper intermediate
B2
Interests
Bio-tech
AI
GLP-1
Neuralink
Business
Finance
Health Legal Landscape
Timeline
Regulatory Affairs Manager
Novo Nordisk
02.2021 - Current
Project Manager Global R&D - Sterile Injectables
Teva Pharmaceuticals
01.2018 - 01.2020
Partner
Family Business Venture
08.2012 - 05.2017
Project Manager Corporate Clients
Regina Maria
11.2010 - 04.2011
Medical Representative Cardiology & Anticoagulants
Egis Pharmaceuticals
06.2009 - 06.2010
Medical Representative Diabetes & Cialis
Eli Lilly
06.2007 - 02.2009
Medical Representative
Berlin-Chemie (Menarini)
11.2005 - 05.2007
Research & Development Analytical Chemist
Alvogen
02.2002 - 11.2005
Master of Science - Quality Control of The Environment
University of Bucharest
04.2001 -
Bachelor of Science - Chemistry (French Language)
University of Bucharest
04.2001 -
Certificate Business - "Managing The Company of The Future"
London Business School (coursera.org)
04.2001 -
Certificate Intellectual Property - "Protecting Innovations Via Trademarks & Patents"
HKUST (coursera.org)
04.2001 -
Language Proficiency Certificate - French Language
Embassy of France in Bucharest
04.2001 -
Certificate in Advanced English (CAE) - Council of Europe Level C1
University of Cambridge & British Council
04.2001 -
Certificate - Professional Negotiation Techniques
Miller Heiman Group (Achieve Global)
04.2001 -
Certificate - Self & Situational Leadership
Ken Blanchard & Eli Lilly
04.2001 -
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