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

Jobs

Interviews

Home
>
Jobs in Hyderabad
>
Horizon Therapeutics
>
Associate Data Management

Associate Data Management

Horizon Therapeutics

1 - 3 years

3 - 7 Lacs

Hyderabad

Posted:2 weeks ago| Platform:

Apply

Skills Required

Training Operations management Basic Data management Compliance Pharma CMC Archiving Information management MHRA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Career Category Operations Job Description

As an Associate, Regulatory Data Management you will help ensure the compliance of our regulatory data via the smooth compliant flow of information across our systems and processes.

Roles & Responsibilities:

Provide support on maintaining our Regulatory Information Management (RIM) system.
Create and archive clinical trial, marketing application submissions and health Authority correspondence within the organisation RIM system.
Serve as a point of contact between regulatory representatives, CMC, safety, partners and the submission management team.
Provide support on creating, running and analysing reports for data streamline projects.
Provide support within data management global team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods.
Adhere to Amgen processes, policies, guidelines, SOPs and training documentations.

Required Knowledge and Skills:

Highly motivated, organised, and detailed oriented team player.
Familiarity with regulatory procedures and filings.
Familiarity with global clinical and regulatory health authorities requirements e. g. FDA, EMA, MHRA etc.

Preferred Knowledge and Skills:

Working knowledge of the Veeva Vault platform is preferred

Basic Education and Experience:

Master s degree and some directly related experience

Bachelor s degree and 2 years of directly related experience

Associate s degree and 4 years of directly related experience

High school diploma / GED and 5+ years of directly related experience

Preferred Education and Experience:

Practical experience with regulatory data standards, such as IDMP

More Jobs at Horizon Therapeutics

Manager, CSAR - SAS Edit Check Programmer

Hyderabad

9.0 - 13.0 yrs

INR 7 - 11 Lacs

Global Regulatory Writing Manager

Hyderabad

4.0 - 12.0 yrs

INR 14 - 18 Lacs

Sr Mgr Project Management - Data Platforms

Hyderabad

8.0 - 14.0 yrs

INR 20 - 25 Lacs

Principal

Hyderabad

10.0 - 14.0 yrs

INR 20 - 25 Lacs

Finance Manager

Hyderabad

5.0 - 12.0 yrs

INR 15 - 20 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

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.