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 Hyderabad
>
Symed Labs
>
Regulatory Affairs - Manager

Regulatory Affairs - Manager

8 - 12 years

|

10 - 13 Lacs

Posted:1 month ago| Platform:

Apply

Skills Required

USFDA Submission Modules query response

Work Mode

Work from Office

Job Type

Full Time

Job Description

Experience in US FDA regulatory submission and query response along with handling of Control correspondence.
Good Knowledge in Current US FDA Guidelines and MAPP
Preparation of Module 1-5, Review and submit through eCTD software. Exposure to 505(j) and 505(b)(2) NCE-1 based submission.
Experience in DMF review.
Prepare, review, and submit regulatory submissions for Product life cycle management.
Collaborate with cross-functional teams (R&D, Quality, Clinical) to ensure regulatory compliance.
Develop and implement regulatory strategies to support product approvals and lifecycle management.
Monitor regulatory intelligence and assess the impact of regulatory changes on the business.
Working knowledge of clinical trial regulations and GxPs.

Proficiency in regulatory software or document management systems

Please share your CVs @ Kavya.c@viyash.com

More Jobs at Symed Labs

Senior Executive - Supply chain Management

Hyderabad

INR 2 - 7 Lacs

Research & Development Executive

Hyderabad

INR 2 - 6 Lacs

Finance & Accounts - Executive / Senior Exceutive

Hyderabad

INR 5 - 10 Lacs

Business Development

Hyderabad

INR 7 - 10 Lacs

Regulatory Affairs - Manager

Hyderabad

INR 10 - 13 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

RecommendedJobs for You

Regulatory Affairs - Manager

Hyderabad

Asst. Mgr. / Mgr - Drug Regulatory Affairs at Corporate Office Ludiana

Leeford Healthcare

Ludhiana, Mohali, Chandigarh

Asst. Mgr. / Mgr - Drug Regulatory Affairs

Leeford Healthcare

Ludhiana, Mohali, Chandigarh

Advocate And Legal Advisor

Bengaluru

Regulatory Affairs and Business Development Associate

Aelius Consultants Delhi

Gurugram

Visa & Compliance Executive

Thane, Navi Mumbai, Mumbai (All Areas)

Company Secretary

Crescendo Finserve

Bengaluru

Compliance Engineer

Bengaluru

Senior Manager / AVP - Legal ( Banking & Finance )

Recsource Recruitment

Chennai, Mumbai (All Areas)

Jr. Officer- Regulatory

Natural Remedies

Bengaluru