Entrepreneur & Managing Director, Clinical Research, Regulatory Affairs, Project Management
Open To Work
ANDREA BORGATTA
Nextrasearch S.r.l.
San Donato Milanese,MI
Work Preference
Job Search Status:
Open to workDesired Job Title
Clinical Trial ManagerRegulatory Affairs ManagerManaging DirectorConsultantCompliance ManagerWork Type
Contract WorkConsultingLocation Preference
On-SiteRemoteHybridLocation:
Milan, MIOpen to relocation:
No29
Years of experience
1
Certification
3
Languages
6
years of post-secondary education
Summary
Entrepreneur and senior executive with 25+ years leading companies through growth, restructuring and international transactions, and with a founder's hands-on track record in clinical research and medical device regulatory affairs since 2022. Combines P&L and general-management ownership with direct project-management delivery of clinical investigations and regulatory strategy for pharma, medical device and aesthetic-medicine clients. GCP certified. Comfortable owning both the business and the science-adjacent regulatory workstream on the same engagement.
Work History
Founder, Managing Director & CFO
4 Years 8 Months- Founded and lead the company end-to-end: business strategy, client development, KOL relationships and full P&L ownership, alongside direct delivery of regulatory and clinical project work.
- Act as strategic designer and project manager on clinical investigations.
- Authored and structurally translated Clinical Evaluation Reports (CER) and produced regulatory deliverables (implant cards, MDR Annex VIII classification analysis) under EU MDR Art. 18 and MDCG guidance.
- Negotiated multicentre Clinical Trial Agreements
- Managed MDD-to-MDR transition gap analyses and regulatory roadmaps for medical device manufacturers and advised on customs/import procedures for CE-marked investigational devices.
- Built a lean-but-networked delivery model, coordinating a partner ecosystem spanning clinical operations, vigilance and regulatory affairs.
- Nextrasearch is a Contract Research Organization (CRO) based in Milan, delivering tailor-made clinical research and regulatory affairs services across pharma, medical devices, cosmeceuticals and food supplements.
Group CFO & Board Director
2 Years 4 Months- Led the integration of the Italian group into the TTD Group as Group CFO; represented the shareholder on the Board
- Italian holding of the Sebach Group, acquired by the German TTD (Toi Toi Dixi) Group, backed by Apax Partners; ~100 employees, €140M consolidated turnover across 4 countries.
CFO
2 Years 11 Months- Acted as project manager for company-wide process and activity reorganization, driving cash and operational efficiency ahead of a successful company sale.
- Italian subsidiary of the Toi Toi Dixi Group (Apax Partners); 65 employees, ~€7M turnover.
CFO & Managing Director
2 Years 7 Months- Steered company strategy with direct responsibility for finance, HR and IT; returned the subsidiary to profitability through demergers and process reorganization.
- Italian branch of the German facility-management group (EQT & PAI Partners); 600+ employees, ~€66M turnover.
Finance Director & Board Member
6 Years- Reduced direct and indirect costs by €2.9M/year and generated 39% cash and profit growth through new credit-management processes and organizational redesign.
- Developed and led a Business Process Outsourcing (BPO) project across finance, IT and payroll.
- Italian branch of a UK hygiene-services group (~250 employees, ~€45M turnover; acquired by CWS Group in 2017).
Finance Director & Board Member
2 Years 1 Month- Reorganized order-to-cash processes, implemented a new IT system and introduced new compliance processes; also held strategic and corporate-governance responsibilities.
- Italian subsidiary of the US CBS outdoor-advertising group; ~90 employees, ~€40M turnover.
Finance Director
10 Years 11 Months- Led finance, IT, HR and legal, with particular focus on extraordinary transactions: M&A, demergers and company sale, working alongside Advent International.
- Italian branch of a Swedish pharmaceutical multinational; ~€100M turnover, 175 employees.
Education
Master of Science - Business Administration
Skills
Clinical trial strategic design and management
EU rules & ISO pharma and MD regulatory
Good Clinical Practice (ICH E6(R3)) certified
Business development & KOL relationship management
Multicenter CTA negotiation (IT / EU / US sites)
Market Access management
M&A
demergers & corporate reorganization
Company founding
governance & P&L ownership
Compliance
ESG & cross-border contract negotiation
Certification
Good Clinical Practice (GCP) ICH E6(R3) certification
MY COMPANY
Nextrasearch is an Italian, AIFA-accredited Contract Research Organization (CRO) based in Milan, serving pharmaceutical, medical device, cosmetic and food supplement companies across Italy, Europe and internationally.
Operating as a pharma consultancy boutique rather than a standard CRO, we deliver tailor-made, cost-efficient solutions through a lean team backed by a network of specialized partners, covering clinical and preclinical research, regulatory affairs (incl. MDR transition and Market Access), quality management (ISO 9001/13485) and pharmacovigilance (QPPV/LQPPV). We support companies exporting their product worldwide making them compliant with local regualtions.
Particular expertise in dermatology, gynaecology, orthopaedics, cardiology and gastroenterology, plus growing activity in medical device MDR transitions and nutraceuticals.
LANGUAGES
- Italian (native)
- English (fluent, negotiation level)
- French (good)
- Spanish (fairly good)
Timeline
Group CFO & Board Director
Sebach Group TTD Holding
01.2023 - 05.2025
Founder, Managing Director & CFO
Nextrasearch S.r.l.
01.2022 - Current
CFO
Toi Toi Italia
01.2020 - 12.2022
CFO & Managing Director
Apleona HSG Italia
05.2018 - 12.2020
Finance Director & Board Member
Initial Italia S.p.A.
04.2012 - 04.2018
Finance Director & Board Member
CBS Outdoor
05.2009 - 06.2011
Finance Director
Meda Pharma
01.1998 - 12.2008
Università Commerciale Luigi Bocconi
Master of Science from Business Administration
09.1986 - 11.1992