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
>
Dr. Reddy's Laboratories
>
Regulatory Associate

Regulatory Associate

Dr. Reddy's Laboratories

5 - 9 years

0 Lacs

hyderabad telangana

Posted:1 week ago| Platform: Shine logo

Apply

Skills Required

regulatory affairs biosimilars biologics ema mhra regulatory submissions design control risk management rd quality clinical manufacturing design verification validation human factors engineering product lifecycle management combination product development global regulatory strategies fda postmarket surveillance labeling updates

Work Mode

On-site

Job Type

Full Time

Job Description

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufacturing considerations. You will lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. Accuracy in regulatory documentation for design control, risk assessment, usability studies, and post-market surveillance will be critical in this position. Collaboration with R&D, Quality, Clinical, and Manufacturing teams is essential to align regulatory strategies with product development. You will also support design verification and validation activities, including human factors engineering (HFE) and risk management. Your role will involve providing regulatory support for product lifecycle management, including manufacturing changes, labeling updates, and device modifications. By leveraging your expertise in regulatory affairs, you will contribute significantly to the success of regulatory processes for biosimilar combination products.,

More Jobs at Dr. Reddy's Laboratories

Team Member - Quality Control

Hyderabad, Telangana, India

3 - 6 yrs

Salary: Not disclosed

Product Manager (Anti allergic medicine)

Mumbai Metropolitan Region

2 - 3 yrs

Salary: Not disclosed

Key Account Manager

Mumbai Metropolitan Region

5 - 8 yrs

Salary: Not disclosed

Territory Business Manager

Patna, Bihar, India

5 - 8 yrs

Salary: Not disclosed

Chemist-Production

Hyderabad, Telangana, India

2 - 6 yrs

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Product Lifecycle Management 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.

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

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

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

Dr. Reddy's Laboratories

Login to

Please Verify Your Phone or Email

Confirm Action

Search

Profile

Upskill and Grow with AI

Regulatory Associate