Regulatory Affairs Junior Coordinator

Posted 08 May 2020

Montevideo - all, Montevideo - Uruguay

Req Id 206071

Details

Qualifications:

 

  • Bachelor’s degree in Pharmaceutical chemistry, Biochemical chemist or other Science degree preferred, 1 year of experience as a regulatory professional desired
  • Know-how in regulatory requirements for the LatAm region is preferred; ability to interpret and apply regulations such as EMA, Anmat, Anvisa, INVIMA & Cofepris are preferred.
  • Excellent verbal and written communications skills, both in English & in Spanish. Portuguese desired.
  • Advanced skills with all standard MS office and business applications
     

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:

 

  • Performs day to day operational activities for Regulatory affairs such as: preparation and assembly of regulatory submissions dossiers, interacting with global, local & regional teams (variations, renewals, new products registration, etc.).
  • Develops and maintains a cooperative working relationship with different stakeholders.
  • Acquires knowledge from the different regulations of the countries within the LatAm region in order to prepare & support the documentation preparation of the dossiers for submission.
  • Supports in the review and approval of labelling materials, and other documents to ensure compliance with the appropriate regulations.
  • Participates in the identification of potential improvements to increase outputs, reduces backlog, and improves business processes.
  • Provide support in assuring the technical content of the communications with the HA agree with the requirements & timelines.
  • Maintains up to date, collects data & run analyses of regulatory systems.

Participates in supporting projects managed in the area.

 

 #TeamMerck y #notintendedforUSorCAvisitors


Qualifications:

 

  • Bachelor’s degree in Pharmaceutical chemistry, Biochemical chemist or other Science degree preferred, 1 year of experience as a regulatory professional desired
  • Know-how in regulatory requirements for the LatAm region is preferred; ability to interpret and apply regulations such as EMA, Anmat, Anvisa, INVIMA & Cofepris are preferred.
  • Excellent verbal and written communications skills, both in English & in Spanish. Portuguese desired.
  • Advanced skills with all standard MS office and business applications
     

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:

 

  • Performs day to day operational activities for Regulatory affairs such as: preparation and assembly of regulatory submissions dossiers, interacting with global, local & regional teams (variations, renewals, new products registration, etc.).
  • Develops and maintains a cooperative working relationship with different stakeholders.
  • Acquires knowledge from the different regulations of the countries within the LatAm region in order to prepare & support the documentation preparation of the dossiers for submission.
  • Supports in the review and approval of labelling materials, and other documents to ensure compliance with the appropriate regulations.
  • Participates in the identification of potential improvements to increase outputs, reduces backlog, and improves business processes.
  • Provide support in assuring the technical content of the communications with the HA agree with the requirements & timelines.
  • Maintains up to date, collects data & run analyses of regulatory systems.

Participates in supporting projects managed in the area.

 

 #TeamMerck y #notintendedforUSorCAvisitors


Qualifications:

 

  • Bachelor’s degree in Pharmaceutical chemistry, Biochemical chemist or other Science degree preferred, 1 year of experience as a regulatory professional desired
  • Know-how in regulatory requirements for the LatAm region is preferred; ability to interpret and apply regulations such as EMA, Anmat, Anvisa, INVIMA & Cofepris are preferred.
  • Excellent verbal and written communications skills, both in English & in Spanish. Portuguese desired.
  • Advanced skills with all standard MS office and business applications
     

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:

 

  • Performs day to day operational activities for Regulatory affairs such as: preparation and assembly of regulatory submissions dossiers, interacting with global, local & regional teams (variations, renewals, new products registration, etc.).
  • Develops and maintains a cooperative working relationship with different stakeholders.
  • Acquires knowledge from the different regulations of the countries within the LatAm region in order to prepare & support the documentation preparation of the dossiers for submission.
  • Supports in the review and approval of labelling materials, and other documents to ensure compliance with the appropriate regulations.
  • Participates in the identification of potential improvements to increase outputs, reduces backlog, and improves business processes.
  • Provide support in assuring the technical content of the communications with the HA agree with the requirements & timelines.
  • Maintains up to date, collects data & run analyses of regulatory systems.

Participates in supporting projects managed in the area.

 

 #TeamMerck y #notintendedforUSorCAvisitors

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