Please complete the CAPTCHA to continue
A concise factual answer block for searchers comparing this professional profile.
André M. is listed as Consultancy Operations Director at ASPHALION at ASPHALION, a company with 106 employees, based in Madrid, Community Of Madrid, Spain. AeroLeads shows a matched LinkedIn profile for André M..
André M. previously worked as Consultancy Operations Director at Asphalion and Director of Regulatory Affairs (CMC & LCM) at Asphalion. André M. holds Postgraduation Study, General Training Program In Business Management from Porto Business School.
This section adds company-level context without repeating André M.'s masked contact details.
Review company-level records connected to André M. before choosing the right outreach path.
Regulatory Affairs Expert:- Quality of Human Medicinal Products- Generics, Biosimilars, Hybrids, Bibliographic Human Medicinal Products- Investigational Medicinal Products (Generics and Innovative Products)- CMC and Bioequivalence- eSubmissions (eCTD & NeeS)- EU Clinical Trial Applications (IMPD for Phase I and Phase II Clinical Trials)- Pharmacovigilance and Safety of Human Medicinal Products- EMA Policy 0070- Project ManagementSpecialties: - EU RA Manager (NP, MRP, DCP)- US RA Manager (505j, 505b1, 505b2 dossiers)- EU/US CMC and bioequivalence support/guidance (pharmaceutical development, marketing authorization applications and marketing authorization maintenance)- EU eCTD Expert- EU/US CMC compliance- Product Information compliance- Management of pharmacovigilance systems- Management of EMA P0070 Policy projects
Company context helps verify the profile and gives searchers a useful next step.
A career timeline built from the work history available for this profile.
Madrid, Community Of Madrid, Spain
Operations Oversight: Supervising Asphalion's consultancy services, ensuring seamless operations/services.Strategic Planning: Strategic planning and critical decisions regarding the consultancy operations/services.Policy Development: Formulate and implement operational policies aimed at enhancing the efficiency and effectiveness of consultancy.
Madrid Area, Spain
Senior Regulatory Affairs Director & Office General Manager (Madrid)Regulatory Affairs CMC & LCM Team Director (+20 line reports; +35 office staff).Wide and consolidated experience in CMC Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in several different markets (EU, USA, Canada, CIS, MENA, ASEAN, LATAM and other RoW.
Madrid E Região, Espanha
RA project lead and management
Barcelona E Região, Espanha
Subject Matter Expert: - CMC pre- and post-approval related matters (chemical entities); including Modules 2.3 and 3 authoring, EU IMPD and US IND authoring (CMC part), dossiers’ gap analysis / due diligence.- Global / full lifecycle management of Generic, Hybrid and Well-established medicinal products, (EU MAA: NP, DCP, MRP; Rest of the World experience.
Uxbridge, United Kingdom (UB8 1LZ)
Team manager in a matrix environment, providing leadership and direction to associates, senior associates, consultants and senior consultants and actively managing employee performance and development.Support business development and contribute to the operational and financial management of the business unit.Scoping of new business opportunities.Subject.
Coimbra Area, Portugal
www.luzitin.ptRoles: RA Manager.Scope: Innovative Investigational Medicinal Products.Main activities and responsibilities:- RA strategy- RA Chemical, Manufacturing and Control (CMC) support- Investigational Medicinal Product Dossier - CMC part- EudraCT registrations- CAS and INN requests
Coimbra Area, Portugal
Roles: RA Manager; eCTD Manager/Expert; Project manager/coordinator (international submissions); RA auditor; PhV support (QPPV deputy); RA trainning.Scope: Generics (semi-solid and solid oral dosage forms), including the Investigational Medicinal Product stage.Main activities and responsibilities:- EU MRP/DCP and NP(PT) MAA submission, maintenance.
Porto Area, Portugal
Roles: RA Manager; eCTD Manager/Expert; RA/PhV liaison.Scope: Non-generics - Innovative (including licensed products) and Bibliographic Products.Main activities and responsibilities:- EU MRP/DCP and NP(PT) MAA submission, maintenance (renewals and variations), pre-submission management. - RA in-house SOP’s creation and implementation.- eSubmissions..
Coimbra Area, Portugal
Roles: RA Manager/Consultant; eCTD Manager/Expert; Project manager (EU DCP/MRP submissions); RA auditor; PhV consultancy.Scope: Generics and Bibliographic Applications (parenteral, semi-solid and solid oral dosage forms).Main activities and responsibilities:- EU MRP/DCP and NP(PT) MAA submission, maintenance (renewals and variations), pre-submission.
Viseu Area, Portugal
Roles: RA Manager (PT National Procedures); PhV Manager (QPPV deputy);Business Administrator of the Company’s Document Management System;Internal Auditor (Quality Management System).Scope: Generics and Bibliographic Applications (parenteral, semi-solid and solid oral dosage forms).Main activities and responsibilities:- NP MAA submissions; NP type I and.
Other employees you can reach at asphalion.com. View company contacts for 106 employees →
Lilena Souza
Colleague at Asphalion
Barcelona, Catalonia, Spain, Spain
View →
DR
David Rubio Herráez
Colleague at Asphalion
Madrid, Community Of Madrid, Spain, Spain
View →
RO
Rubén Onivenis Muñoz
Colleague at Asphalion
Badajoz, Extremadura, Spain, Spain
View →
PB
Pilar Blázquez San Miguel
Colleague at Asphalion
Greater Barcelona Metropolitan Area, Spain
View →
AP
Alba Palacios Puig
Colleague at Asphalion
Spain, Spain
View →
EA
Edward Alexis Taborda Bernal
Colleague at Asphalion
Puerto Libertador, Córdoba, Colombia, Colombia
View →
TK
Tatiana Karpova
Colleague at Asphalion
Barcelona, Catalonia, Spain, Spain
View →
EF
Esther F.
Colleague at Asphalion
Spain, Spain
View →
PS
Pablo Serrano Giménez
Colleague at Asphalion
Barcelona, Catalonia, Spain, Spain
View →
JK
James Kenny
Colleague at Asphalion
Almería, Andalusia, Spain, Spain
View →
General training program in business management (96 hours): - Strategy and strategic planning - Economics for managers (macroeconomics).
- Solid Dosage Forms/Systems; - Liquid Dosage Forms/Systems; - Semisolid Dosage Forms/Systems; - Modified Release Dosage Forms.
Erasmus Program - Faculty of Pharmacy - Pharmaceutical Technology Department
Quick answers generated from the profile data available on this page.
André M. works for ASPHALION.
André M. is listed as Consultancy Operations Director at ASPHALION at ASPHALION.
André M. is based in Madrid, Community Of Madrid, Spain while working with ASPHALION.
André M. has worked for Asphalion, Pharmamar, Parexel, Luzitin, and Bluepharma.
André M.'s colleagues at ASPHALION include Lilena Souza, David Rubio Herráez, Rubén Onivenis Muñoz, Pilar Blázquez San Miguel, and Alba Palacios Puig.
You can use AeroLeads to view verified contact signals for André M. at ASPHALION, including work email, phone, and LinkedIn data when available.
André M. holds Postgraduation Study, General Training Program In Business Management from Porto Business School.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contactsCheck these profiles if this is not the André M. you were looking for.
