Karem Needham

Karem Needham Email and Phone Number

Technical Director and Regulatory Affairs @ Heel Chile
Chile
Karem Needham's Location
Chile, Chile
Karem Needham's Contact Details

Karem Needham personal email

n/a
About Karem Needham

Main activities:Leadership public relation with BOH entitiesMarketing Approval Authorizations Notable Work Accomplishments: • BE Reference status for GSK CH product.• New claims for OTC GSK product • First registrations in Chile of Bioequivalence oncology products Synthon. • Introduction of New Medical Device in Chile.Top Three Strengths & Capabilities: Proactiveness & Resilience skills EnglishHelps resolves conflicts

Karem Needham's Current Company Details
Heel Chile

Heel Chile

View
Technical Director and Regulatory Affairs
Chile
Website:
heel.cl
Employees:
11
Karem Needham Work Experience Details
  • Heel Chile
    Technical Director And Regulatory Affairs
    Heel Chile
    Chile
  • Heel Chile
    Technical Director & Regulatory Affairs
    Heel Chile Jan 2021 - Present
    Chile
  • Laboratorio Maver S.A.
    Director Técnico & Regulatory Affairs
    Laboratorio Maver S.A. May 2020 - Jan 2021
  • Laboratorio Maver S.A.
    Responsable Asuntos Regulatorios
    Laboratorio Maver S.A. Feb 2020 - May 2020
  • Representaciones Biotec Ltda
    Director Tecnico & Regulatory Affairs
    Representaciones Biotec Ltda Mar 2019 - Feb 2020
    Santiago Province, Chile
  • Gsk
    Regulatory Affairs Manager Chc
    Gsk Nov 2011 - Mar 2019
    Chile
    • Ensure products within scope can be launched / maintained; meeting internal and external compliance requirements, with optimal yet compliant claims, in line with commercial plans.• Be part of Executive Managers Chile GSK CH providing input into regulatory strategies and process improvement/compliance activities, sharing business approaches, proactively identifying potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business.• Engage with the external regulatory environment acting as a responsible voice of GSK CH Chile with local regulators, trade associations and other key external regulatory bodies; representing GSK in a responsible manner according to company values.• Work together with LATINA regulatory colleagues and GLOBAL stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.• Be a proactive partner to other stakeholders, e.g., marketing/sales, supply chain and quality etc. analyzing regulatory issues and communicate effectively with key stakeholders. • Manage compliance within defined portfolio/activity streams in line with GSK CH expectations - support key processes and ways of working (e.g., in relation to GSK CMC, quality, product labeling requirements as well as local MoH regulations). Propose solutions to identified issues and implement.• Maintain required regulatory compliance databases, systems and processes.
  • Synthon
    Regulatory Affairs Chief
    Synthon Feb 2010 - Nov 2011
  • Quimick
    Key Account Manager.
    Quimick Nov 2008 - Feb 2010
  • Merck Healthcare
    Regulatory Affairs Coordinator
    Merck Healthcare Mar 2007 - Sep 2008
  • Pfizer
    Regulatory Affairs Southern Cone
    Pfizer Sep 2001 - Feb 2007

Karem Needham Skills

Regulatory Affairs Asuntos Normativos Pharmaceutical Industry Team Leadership Strategy Regulatory Submissions

Karem Needham Education Details

Frequently Asked Questions about Karem Needham

What company does Karem Needham work for?

Karem Needham works for Heel Chile

What is Karem Needham's role at the current company?

Karem Needham's current role is Technical Director and Regulatory Affairs.

What is Karem Needham's email address?

Karem Needham's email address is ka****@****gsk.com

What schools did Karem Needham attend?

Karem Needham attended Universidad De Chile, Universidad Diego Portales.

What skills is Karem Needham known for?

Karem Needham has skills like Regulatory Affairs, Asuntos Normativos, Pharmaceutical Industry, Team Leadership, Strategy, Regulatory Submissions.

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