Regulatory Affairs Specialist
Merck Sharp & Dohme Corp.
Vicente López, Buenos Aires, Argentina
hace 56 días

Description

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company.

Today, we’re doubling down on this goal. MRL is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-

class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases

Position Objectives

Assuring quality of data and timely development and successful regulatory approval of marketing applications for new products.

Oversight of all other functional units that are involved in the process of marketing applications. Ensuring effective communication between the company and Regulatory Agencies charged with the review of new applications and maintenance of existing licenses.

Interprets federal and state and / or international regulations as they apply to products, financial processes, and other processes, practices and procedures.

Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and that regulatory reporting requirements are met.

Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.

May develop and implement programs designed to increase employee awareness and knowledge of compliance policies. May audit and evaluate current policies, procedures, and documentation for compliance with government laws and regulations.

Main Responsibilities

  • The main objective of the position is to support cardiometabolic products portfolio (diabetes, hypertension and hypercholesterolemia).
  • Responsible for formulating the strategy for new products registration and life cycle management (LCM) in alignment with clinical plans and marketing objectives.
  • Acts as an internal consultant and a facilitator for Regional GRA Franchises
  • Responsible for the implementation and operation of new products registration and life cycle management (LCM) franchising for Argentina
  • Act as Liaison together with RA Country Lead before ANMAT / INAME to develop solutions consistent with MSD strategy and registration requirements.
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