Job opening for Regulatory Associate@ Merck Life Sciences

Posted on 23/07/2020

Merck Life Sciences Regulatory Associate Job – Applications Invited

Merck Life Sciences Regulatory Associate Job – Applications Invited. Life Science candidates apply online for Senior Associate Regulatory Submission Management position at Merck. Interested and eligible candidates check all the below:

Job Title: Senior Associate Regulatory Submission Management

– Advertisement –

Job Requisition ID: 207691

Location: Bangalore SBS

Purpose of the Role: Manage and also 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 regulatory submissions to Health Authorities for development products (e.g. IND new investigator-, IND Safety Report-, Ad Promo submissions) during the product lifecycle in cooperation with the Regulatory Project Manager and also TA responsible.
  • Authors cover letter and also application forms for eCTD lifecycle submissions (e.g. IND new investigators, IND Amendment).
  • Creates, updates Virtual Documents (” Digital Dossier”) and Submission Content Plan (SCP) for eCTD lifecycle submissions.
  • Creates, updates entries in Regulatory Info 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.
  • Publishes Promotional Labeling and Advertising Materials (” Ad Promo”) submissions in eCTD lifecycle making use of publishing tool.
  • Collaborates with publishing vendor and checks published output (technological QC spot check).
  • Resolves coordinates any inquiries of publishing vendor.

Requirements:

Education/languages:

  • Degree in a Life Science or related discipline
  • Minimum 2 years experience in Regulatory Affairs/Regulatory Operations environment (Publishing, Submission Management).
  • Outstanding spoken and written English.

Professional skills and also experience: The proven capability to handle software and also databases needed to support the regulatory function according to the role.

Personal skills as well as competencies:

  • Outstanding communication skills.
  • Excellent interpersonal skills.
  • Attention to details.
  • Great teamwork abilities.
  • Flexibility to work in US shift timing.

Apply Online