Regulatory Affairs Associate Manager

Posted 06 Dec 2019

Montevideo - all, Montevideo - Uruguay

Req Id 201070

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Qualifications:

  • Bachelors Degree in Pharmaceutical chemistry, Biochemical chemist or other Science degree preferred, with minimum of 6years of experience including post-marketing regulatory affairs.
  • At least 5 years of experience in positions leading high performance teams.
  • Excellent verbal and written communications skills, both in English & in Spanish.
  • Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
  • Demonstrated expertise in regulatory requirements; ability to interpret and apply regulations (EMA, ICH, Cofepris, Invima and other) to specific projects.
  • Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.
  • Proficiency in use of databases MS office & applications (Word, Excel, Power point Skype)
  • Demonstrates an advanced ability to project outputs.
  • Manages multiple, medium to high complex projects with internal & external partners.
  • Possesses advanced analytical skills with the ability to interpret data/information and its practical application.
  • Budget management for a team is required.
  • Availabilty to travel is needed.
    Fundamental Skills:
  • Leadership
  • Collaborative (team work)
  • Flexible & adaptable to change
  • Negotiation habilities
  • Results oriented ( hability to work under pressuer & tight deadlines)
  • People person; focused on people development
  • Able to work independently
  • Good & open communication
  • Multitasking (Hability to work with different projects simultaneously)
  • Problem solver
  • Resilience

 

 Main position activities:

  • Lead, build & manage a professional team in Regulatory Affairs department for the products & countries under his/her responsibility.
  • Participate & contribute to the Regulatory strategy to reach the current & future objectives aligned with the business & other functions.
  • Ensure high quality planning, creation & compilation of regulatory submissions within the LatAm region, as per company target deadlines & country laws & regulations.
  • Ensure that all due dates for regulatory milestones for pre- & post- approval submissions are met.
  • Monitors, analyzes and raises awareness and assesses impact of regulatory issues for stakeholders inside and outside of regulatory affairs.
  • Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential.
  • Contributes to the continuous improvement of existing department processes and strategies, providing recommendations in area of expertise
  • Establish strong relationships with Regulatory affairs colleagues within the region, global & cross-functionaly.
  • Ensures that regulatory files and data systems are maintained and in compliance with related work instructions and regulations.

 

#NotintendedforUSorCAvisitors #TeamMerck


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Apply Now

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