Specialist Regional Submissions Planner
MSD
Panama City, Panamá, Panama
hace 22 horas

Join our team!

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies.

We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Regulatory Submissions Planner will work within Global Regulatory Affairs and Clinical Safety organization, in the Regulatory Affairs Operations International Latin America department in Panamá.

Also, assists the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole of the Latin America region.

As a member of cross-functional team and for the assigned products, the Regulatory Submissions Planner will manage all operational aspects for submission planning and execution of Original Marketing Application and post-approval regulatory changes.

This position requires a high-level expertise and knowledge of the regulatory landscape across the Latin America Region, its registration procedures and a thorough mastery of the technical specifications for dossiers.

Primary Activities include but are not limited to :

  • Planning and managing regulatory operation projects from authorization through delivery to country regulatory affairs teams and / or Health Authorities.
  • Responsible for developing and maintaining the regulatory submission plan for the assigned projects / products and maintaining the related project milestones.
  • Participate in cross-functional forums and meetings.
  • Work closely with the central planner based in the Headquarters on assigned products / projects.
  • Drive the submission assembly and delivery process with the Global and / or Regional Submission Publishing team to ensure timely assembly, publishing and archival of assigned products / submissions as per the agreed timelines.
  • Responsible for accessing and maintaining the regulatory systems and databases to fulfil daily functions.
  • Assist in identifying opportunities to continually improve the efficiency of the submission process and participate in small-scale process improvement projects.
  • Maintain knowledge on the regional regulatory procedures on internal and external guidelines and standards.
  • Education Requirements :

  • Bachelor’s degree in a Life Science, Pharmacy, Engineering, or IT.
  • Experience and Skills :

  • At least one (1) year’ experience in the regulatory operations area (submission planning and publishing).
  • Regulatory affairs experience will be an asset.
  • Proficiency in Spanish and English, in oral and written.
  • Willing to travel up to 10% of the time.
  • Thorough knowledge of regulatory guidelines and procedures within the Latin America region is preferred.
  • Excellent communication skills to manage interactions with colleagues in a multicultural environment.
  • Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers.
  • Ability to handle time pressure and the consequence of any delay in timely submissions.
  • Affinity to work with complex IT systems.
  • We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world.

    We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

    Who we are

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

    Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    What we look for

    Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity.

    You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

    Our team is constantly evolving, so if you are among the intellectually curious, join us and start making your impact today.

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

    We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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