Regulatory Affairs Specialist
Merck Sharp & Dohme Corp.
Vicente López, AR
hace 9 días

Regulatory Affairs Specialist Job

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Enter your email to apply Requisition ID : REG003772

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.
  • Competencies

  • Demonstrates effective communication skills. Accurately and effectively communicates position and information to peers, supervisors, teams and external professional contacts.
  • Demonstrates strong cross-functional teamwork skills to ensure new products launch in the projected timeline mostly coordinating different involved areas activities (i.
  • e, Product Managers, Medical Advisors, QA / QC, Supply / Logistics).

  • Ability to function as a consultant to internal clients, providing then with expert advice on Regulatory issues.
  • Ability to proactively analyze competitive information and strategize, collaborate and build consensus for offensive and defensive approaches with brand teams for promotional campaigns, new indications and / or strategic labeling changes for marketed products.
  • Demonstrates good project management skills by monitoring project timelines ensuring filing of new products, line extensions and variations timelines are met in accordance with business objectives
  • Create new and innovative ways of doing and perceiving things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.
  • Integrate effectively the expected and unexpected changes keeping in mind overall MSD interest
  • Qualifications & Experience

    Education

  • Science Degree or advanced student (pharmacist, biochemist, biology, biotech, genetics)
  • Good level in English.
  • Experience

  • Consolidated experience in regulatory affairs for at least 2 years in multinational companies.
  • Good knowledge of the key processes, guidelines and framework related.
  • Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    At MSD, we’re inventing for life.

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