Regulatory Specialist

Posted 12 May 2019

Bangalore SBS, Karnataka - India

Req Id 192057

Details

A career is an ongoing journey of discovery: our 51,000 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.


A career at Merck is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

PURPOSE OF THE POSITION

Manage and provide follow-up on the preparation of regulatory documentation for submission to Health Authorities worldwide.

 

MAIN INTERFACES

Regulatory Project Manager, Global Regulatory Lead, Country Regulatory Affairs, Other Global Regulatory Affairs functions, CMC functions, Global Clinical Operations, Global Patient Safety, Global Clinical Development, Externally: Publishing Vendor.

 

KEY TASKS AND RESPONSIBILITIES

  • Processes routine submissions for development products (e.g. IND new investigator submissions, IND Safety Reports) during the product lifecycle in cooperation with the Regulatory Project Manager and TA responsible.
  • Authors cover letter and application forms for routine submissions (e.g. IND new investigators, IND Amendment).
  • Creates, updates Virtual Documents (“Digital Dossier”) and Submission Content Plan (SCP) for routine submissions. Creates, updates entries in Regulatory Information Management System (RIMS).
  • Liaises with Global Clinical Operations (GCO) to provide FDA 1572 forms, Investigator CVs, Clinical documents (Study Protocol, ICF) in a submission-ready format.
  • Collaborates with publishing vendor and checks published output (technical QC spot check).
  • Resolves, coordinates any queries of publishing vendor.
     
     

BASIC QUALIFICATIONS

 

Education:

  • Degree in a Life Science or related discipline.
  • Minimum 1 year experience in Regulatory Affairs/Regulatory Operations environment (publishing, submission management).
  • Excellent spoken and written English.

 

Professional skills and experience:

  • Proven ability to handle software and databases needed to support the regulatory function according to the role.

 

Personal skills and competencies:

  • Excellent communication skills
  • Excellent interpersonal skills
  • Attention to details
  • Good teamwork skills

 

What we offer: 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


What we offer: At Merck, 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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