Regulatory Affairs Senior Liason

Posted 23 Apr 2020

Montevideo - all, Montevideo - Uruguay

Req Id 205814

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 6 years of experience as a regulatory professional
  • At least 1 year of leadership experience is preferred
  • Know-how in regulatory requirements for the LatAm region; ability to interpret and apply regulations such as EMA, Anmat, Anvisa, INVIMA & Cofepris are preferred.
  • Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements.
  • This position serves as a subject matter expert on new & revised regulations, guidelines and coordinates regulatory issues resolution to ensure complete & scientifically complete products submissions.
  • Identifies and drafts regional/local and global strategies, registration plans and generates options to obtain product approvals and support product changes.
  • Participates in business meetings with cross-functional teams & external customers and provides active and ongoing guidance within submission projects.
  • Conducts trainings & /or communicates materials to enhance team´s knowledge of working in a regulated environment.
  • Assists Regulatory department in the update, enhancement & creation of internal procedures.
  • Interacts with regulatory agencies & associations.
  • Research regulations, competitor products & creates summaries for departamental use.
  • Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
  • Excellent verbal and written communications skills, both in English & in Spanish.
  • Ability to interact effectively with all levels of management.
  • Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.
  • Advanced skills with all standard MS office and business applications
  • Possesses advanced analytical skills with the ability to interpret data/information and repot it accordingly.
  • Availabilty to travel is needed.

 

Fundamental Skills:

  • Collaborative (team work)
  • Flexible & adaptable to change
  • Results oriented (ability to work under pressure & tight deadlines)
  • Able to work independently
  • Good & open communication
  • Multitasking (ability to work with different projects simultaneously)
  • Problem solver
  • Resilience

 

 Main position activities:

  • To develop & implement the regulatory affairs strategy for biopharmaceutical products.
  • To manage, conduct & lead HA meetings, preparations & submissions.
  • Interpret, communicate regulatory expectations, develop strategies and risk assessments to internal & external stakeholders in order to execute and achieve submission timelines in compliance with applicable regulations.
  • Will be accountable for the effective planning, management, reporting and coordination of submission processes to the HA within LatAm region
  • Serve as the subject matter expert on Regulatory Affairs for the organization. 
  • Performs analyses, develops recommendations, and prepares communications to transmit them to senior Regulatory leaders.
  • Manage relationships & have a fluent communication with third parties, cross functional stakeholders & other partners to attain performance & identify or solve problems that arise & are critical within the submission processes.

#TeamMerck #NotintendedforUSorCAvisitors


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

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