Lamia Belabbes

Head, Regulatory Affaires @Euro-Pharm International Canada Inc

Montreal, QC, CA
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2022 — Present

Head, Regulatory Affaires @Euro-Pharm International Canada Inc

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EDUCATION

2005 — 2006

Université de Montréal

Master of pharmaceutical Science degree (M.Sc

2002 — 2004

Université de Montréal

Pending PhD.Chem

2003 — 2005

Université de Montréal

DESS (Diplôme d’études supérieures spécialisées)

SKILLS

Regulatory SubmissionsBiotechnologyStandard Operating Procedure (Sop)FdaGlpTechnology TransferClinical TrialsRegulatory RequirementsScienceChange ControlRegulatory AffairsDrug DevelopmentPharmaceutical IndustrySopHigh-Performance Liquid Chromatography (Hplc)PharmacovigilanceGmpU.s. Food and Drug Administration (Fda)ValidationPharmaceuticsCapaGood Laboratory Practice (Glp)

ABOUT LAMIA BELABBES

Direct experience in drug development from Synthesis of active substrate to commercial production. A minimum of 20 years experience in the Pharmaceutical industry and 14 years experience in Pharmaceutical Quality and Regulatory. Distinctive assets: Leadership, Emotional Intelligence; Professional code of ethics. Sense of social and public relations skills; Ability to function within a multidisplinary team; Excellent planning, time management and organisational skills. Aggressively cultivate and promote a positive and innovative work environment. Strong negotiation skills. • Ability to lead and organize more than one team and knowledge/discipline at one time. Ability to identify people and activities that influence organizational processes and political nuances. Awareness of: Working knowledge of International and Local Regulations Experience with compiling, writing, submitting and managing approvals of DIN applications, S/NDS that include C&M, clinical safety and efficacy data; Experience with submitting and managing approvals of PAAB approvals; Quality Assurance; Clinical studies; Medical information; Pharmacovigilance Chemistry and drug manufacturing; Strategic planification; Pharmacotechnical; Therapeutic chemistry (synthesis and therapeutic activity studies); Pharmaco-modulation (study of prodrugs ); Spectroscopic analyses (RMN 1D, 2D, 3D); Chromatographic analyses (CCM, CC, HPLC, CPG); Physico-chemical analyses.

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Lamia Belabbes — Head, Regulatory Affaires at Euro-Pharm International Canada Inc in Montreal, QC, CA | Unifers