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
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.
- 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.
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