Jobs

Interviews
Job Alerts
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

Co-Pilot (Chrome Extension) Your AI Assistant for Seamless Browsing Efficiency

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

Interviews

Home
>
Jobs in ahmedabad
>
Dishman Carbogen Amcis
>
Sr. Officer To Asst.Manager - Regulatory Affairs (Formulation & API)

Sr. Officer To Asst.Manager - Regulatory Affairs (Formulation & API)

Dishman Carbogen Amcis

5 - 10 years

|

4 - 8 Lacs

Posted:1 day ago| Platform:

Apply

Skills Required

regulatory affairs drug regulatory affairs dossier preparation monograph europe market gmp actd ra ich usfda ctd row market dossier edqm dmf regulatory compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines.
Response preparation as per the query
Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations
Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements
Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier.
Assist in preparation of dossier as per country specific requirement.
Any other job assigned by immediate supervisor/HOD

Preferred candidate profile

Hiring for API & Formulation background candidates for Regulatory Affairs Team
Good Communication Skill in English

More Jobs at Dishman Carbogen Amcis

Officer - QC

Ahmedabad

INR 3 - 4 Lacs

Engineer - Electrical

Ahmedabad

INR 3 - 9 Lacs

Assistant

Jamnagar, Ahmedabad, Rajkot, Surat, Vadodara

INR 4 - 7 Lacs

Manager - Purchase

Ahmedabad

14.0 - 16.0 yrs

INR 11 - 13 Lacs

Operator - Production

Ahmedabad

INR 3 - 9 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Google Play

App Store

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

Dishman Carbogen Amcis

Pharmaceuticals

Ahmedabad

RecommendedJobs for You

Sr. Officer To Asst.Manager - Regulatory Affairs (Formulation & API)

Dishman Carbogen Amcis

ahmedabad

Business Development Manager

Talisman Hr Solutions

mumbai suburban, bengaluru, mumbai (all areas)

Influencer Marketing Specialist

Vipsa Talent Solutions

gurugram, bengaluru

SAP BTP Admin

Vbeyond Corporation

noida, kolkata, bengaluru

Company Secretary

Red Envelope Consultants

ahmedabad

Spare Parts Executive - Bangalore

Phillips Machine Tools

bengaluru

Walk-in drive For "Order Management" at Pune on 25th Aug 25

pune

Executive / Senior Executive

Aurobindo Pharma

hyderabad

Admission Counsellor

Varin Communications

hyderabad

Spare Parts Executive - Additive (Navi Mumbai)

Phillips Machine Tools

navi mumbai