Jobs

Tools

Upskill and Grow with AI

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Path AI insights for smarter career decisions

AI Job Match Score AI-Powered Job Match Against Your Resume and Optimize Your Resume

Career Tools and Resources

Resume Builder Build Professional Resume with Ease

ATS Friendliness Check Check Resume Friendliness for Applicant Tracking Systems

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
For Employers

Home

Jobs

Companies

Resume

Home
>
Jobs in Bengaluru
>
Vueverse Consulting Services (opc)
>
Regulatory Affairs-CMC (Junior-Senior level)

Regulatory Affairs-CMC (Junior-Senior level)

Vueverse Consulting Services (opc)

4 - 9 years

6 - 15 Lacs

Bengaluru

Posted:1 month ago| Platform:

Apply

Skills Required

CMC module 3 eCTD dossier compilation Regulatory Affairs Regulatory Documentation

Work Mode

Remote

Job Type

Full Time

Job Description

Title: Regulatory Affairs-CMC (Junior-Senior level) Location: 100% REMOTE Experience: 4-14 Years Industry: Pharmaceuticals / Life Sciences Job Overview Join our team as a Regulatory Affairs Specialist with 4-14 years of experience in pharmaceuticals or life sciences. We seek a detail-oriented professional skilled in CMC Module 3 preparation and eCTD dossier compilation to ensure compliance with global and Asia market regulatory standards. Key Responsibilities eCTD Dossier Compilation : Draft, Review and compile CTD/eCTD modules, ensuring accuracy, consistency, and alignment of Modules 2.5, 2.7, 3 and 5 with biosimilar justifications. Conduct gap analyses and coordinate corrections. Regulatory Compliance : Support health authority query responses, internal audits, and inspections, ensuring adherence to SOPs and APAC regulations. Collaboration & Training : Act as the regulatory lead for biosimilar projects, train teams on APAC eCTD requirements, and align with CMC, Clinical, and Quality teams for data integrity. Required Qualifications 4-14 years in regulatory affairs (pharma/life sciences). Experience in reviewing documentation related to biosimilars submissions across Asia markets Expertise in CMC Module 3 , eCTD compilation , and APAC regulations (PMDA, NMPA, DCGI). Bachelors/Masters in Pharmacy or Life Sciences. Strong attention to detail and ability to meet deadlines.

More Jobs at Vueverse Consulting Services (opc)

Regulatory Affairs-CMC (Junior-Senior level)

Bengaluru

4 - 9 yrs

INR 6 - 15 Lacs

Business Development Executive

Hyderabad

1.0 - 3.0 yrs

INR 0 - 0 Lacs

Business Development Manager

Hyderabad

4.0 - 8.0 yrs

INR 0 - 0 Lacs

Market Research Analyst

Hyderabad

1.0 - 3.0 yrs

INR 0 - 1 Lacs

Veeva Vault SME - Lead (QMS, LMS, DMS)

Navi Mumbai

5.0 - 10.0 yrs

INR 0 - 0 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Cmc Module 3 Interview Now

My Connections Vueverse Consulting Services (opc)

Download Chrome Extension (See your connection in the Vueverse Consulting Services (opc) )

Download Now

Vueverse Consulting Services (opc)

5 Jobs

Login to

Please Verify Your Phone or Email

Confirm Action

Search

Profile

Bookmarks

Regulatory Affairs-CMC (Junior-Senior level)

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

More Jobs at Vueverse Consulting Services (opc)

Mock Interview

Download Chrome Extension (See your connection in the Vueverse Consulting Services (opc) )

RecommendedJobs for You

Regulatory Affairs-CMC (Junior-Senior level)

Service Coordinator

Product Development Executive

Biostatistical Programmer

Jobs For 16-25 passout Biotechnology Engineers,Biomedical Engineers

Jobs For 16-25 passout Lifescience & Paramedical Freshers

Head Manufacturing - OSD

Pharmacist

Hiring Pharmacist

Hiring Pharmacist

Login to

Please Verify Your Phone or Email

Confirm Action

Contact Us

Search

Profile

Bookmarks

Personal Settings

Regulatory Affairs-CMC (Junior-Senior level)

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

More Jobs at Vueverse Consulting Services (opc)