Bengaluru Karnataka Regulatory affair Jobs – 44 Open Jobs Today

Regulatory Affairs Associate
TrialGuna Pvt Ltd —Bengaluru, Karnataka
- ₹4,50,000 - ₹5,00,000 a year
- Full-time
- English
- Master's degree
- Analysis skills
- Paid time off
- Cell phone reimbursement
Quick apply
11d
Regulatory Affairs Specialist
Natus Sensory —Bengaluru, Karnataka
- Full-time
- Remote
- English
- Continuous improvement
- Health insurance
- Paid time off
Regulatory Affairs Specialist
Dozee —Bengaluru, Karnataka
- Full-time
- Project management
- Bachelor's degree
- AI
1d
Specialist - Regulatory Affairs - Operations 4A
Genpact India Pvt. Ltd. —Bengaluru, Karnataka
- Full-time
- English
- Master's degree
- Bachelor's degree
Quick apply
Regulatory Affairs Specialist
ZEISS Group —Bengaluru, Karnataka
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Regulatory Affairs Specialist
Masimo —Bengaluru, Karnataka
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Access
Regulatory Professional II
Novo Nordisk —Bengaluru, Karnataka
- English
- Master's degree
- Project management
21h
Regulatory Affairs Manager I
Zimmer Biomet —Bengaluru, Karnataka
- Full-time
- Analysis skills
- Bachelor's degree
- Travel
2d
Regulatory Affairs Expert
Fresenius Medical Care —Bengaluru, Karnataka
- Full-time
- Engineering
- English
- Master's degree
Principal Specialist, Regulatory Affairs
Baxter —Bengaluru, Karnataka
- English
- Master's degree
- Electrical experience
4h
LifeScience Regulatory Svs Associate
Accenture —Bengaluru, Karnataka
- Full-time
- Master's degree
7d
International CMC Regulatory Affairs Manager I
AstraZeneca —Bengaluru, Karnataka
- Full-time
- PMP
- Research
- Project management
10d
Regulatory Affairs Operations Manager
Monster Energy APAC —Bengaluru, Karnataka
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Specialist- Regulatory Affairs Process Digitalization & AI
Fresenius Medical Care —Bengaluru, Karnataka
- Full-time
- Azure
- AWS
- SharePoint
RC-REGULATORY COMPLIANCE-Regulatory - SME-Senior Manager
EY —Bengaluru, Karnataka
- Management
- PMP
- Analysis skills
Regulatory Affairs Manager
ZEISS Group —Bengaluru, Karnataka
- Full-time
- Bachelor's degree
- AI
- Communication skills
Senior Regulatory Affairs
Saraca Solutions —Bengaluru, Karnataka
- Bachelor's degree
- Travel
- Communication skills
Executive - Regulatory Affairs
Halma India Private Limited —Bengaluru, Karnataka
- Full-time
- Agile
- Communication skills
Quick apply
10d
Senior Regulatory Affairs (RA) Specialist
Healthminds Consulting —Bengaluru, Karnataka
- Full-time
- Master's degree
- Analysis skills
- Bachelor's degree
Learning and Development – Dialysis Training & Clinical Quality
Lord's Mark Industries Limited —Kengeri, Bengaluru, Karnataka
- ₹2,37,675.44 - ₹5,00,000.00 a year
- Full-time
- B.Sc
- Bachelor's degree
- In-person
Quick apply
11d

I want to receive the latest job alerts for regulatory affair in bengaluru karnataka

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affair jobs near bengaluru karnataka

Regulatory Affairs Specialist jobs in Bengaluru, Karnataka

Compliance Manager jobs in Bengaluru, Karnataka

Regulatory Affairs Manager jobs in Bengaluru, Karnataka

Life Science Consultant jobs in Bengaluru, Karnataka

Regulatory Affairs Manager jobs in Ahmedabad, Gujarat

Regulatory Affairs Manager jobs in Navi Mumbai, Maharashtra

Regulatory Affairs Manager jobs in Mumbai, Maharashtra

Purchase Manager jobs in Kerala

Event Manager jobs in Bengaluru, Karnataka

Ai Product Manager jobs in Chennai, Tamil Nadu

Business Development Manager jobs in Mumbai, Maharashtra

Regulatory Affairs Specialist jobs in Ahmedabad, Gujarat

Regulatory Affairs Specialist jobs in Electronics City, Bengaluru, Karnataka

Regulatory Affairs, Remote jobs in Bengaluru, Karnataka

Regulatory Affairs Specialist jobs in Bopal, Ahmedabad, Gujarat

Regulatory Affairs, Freshers jobs in Pune, Maharashtra

Regulatory Affairs Specialist jobs in Kochi, Kerala

Clinical Application Specialist jobs in Chennai, Tamil Nadu

Regulatory Affairs Specialist jobs in Kukatpally, Hyderabad, Telangana

Regulatory jobs in Pune, Maharashtra

Regulatory Affairs Associate

TrialGuna Pvt Ltd
Bengaluru, Karnataka

Quick apply

Job details

Full-time
₹4,50,000 - ₹5,00,000 a year
11 days ago

Benefits

Provident Fund
Paid time off
Cell phone reimbursement
Flexible schedule

Qualifications

Biotechnology
English
Master's degree
Analysis skills
Bachelor's degree
Communication skills

Full job description

Position: Regulatory Affairs Associate

Department: Scientific and Regulatory Affairs

Location: Bengaluru, Karnataka (On- Site)

Reporting To: Manager, Scientific and Regulatory Affairs

Role Overview:

Regulatory Affairs Associate with experience to develop, review, and manage high-quality regulatory documentation in compliance with applicable guidelines and standards.

Key Responsibilities:

· Prepare, review, and coordinate regulatory submissions, including applications for approvals, amendments, and clarifications.

· Track and follow up on submission status and ensure timely responses to queries raised by regulatory agencies.

· Prepare and submit regulatory amendments, notifications, responses to deficiency letters, and supporting documentation within prescribed timelines.

· Review regulatory dossiers and supporting documents for accuracy, consistency, and compliance with current regulatory requirements.

· Facilitate and coordinate meetings, presentations, and discussions with regulatory officials to support ongoing and upcoming projects.

· Maintain updated knowledge of Indian regulatory frameworks, including CDSCO MDR 2017, NDCT rules 2019, Drugs and Cosmetics Act and Rules, ICMR guidelines, and other applicable standards.

· Draft and review regulatory correspondence, meeting notes, and briefing documents.

· Contribute to SOP development, revision, and implementation.

· Develop, maintain, and update related templates, forms, checklists, logs, and standard document formats.

· Ensure controlled documents are current, approved, and available to project teams.

· Support implementation and continuous improvement of documentation processes.

· Maintain document repositories.

· Assist in audit and inspection readiness activities.

· Maintain meeting minutes, project trackers for all regulatory deliverables.

· Track document progress, review status, comments reconciliation, and approval workflows.

· Track key milestones, deliverables, and project timelines.

· Identify potential delays and proactively escalate risks to project stakeholders.

· Provide regular status updates and project reports.

· Schedule review meetings, collect feedback, and facilitate resolution of review comments.

· Support vendor and consultant management activities related to regulatory projects.

· Ensure effective communication among cross-functional teams.

Qualifications & Skills:

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related field.
2-5 years of experience in regulatory affairs within pharmaceutical, medical device, CRO, or healthcare industries.
Working knowledge of applicable regulatory requirements and guidelines, including CDSCO, ICH-GCP, NDCT Rules, Medical Device Rules, and global regulatory frameworks where applicable.
Hands-on experience with regulatory submissions, amendments, notifications, responses to regulatory queries, and maintenance of regulatory records throughout the study lifecycle.
Strong written and verbal communication skills with excellent attention to detail and document quality.
Good command over English language, communication and interpersonal skills for effective interaction with the regulatory personnel and stakeholders.
Experience in preparation and maintenance of the study documentation and regulatory submission forms.
Strong analytical to interpret clinical and regulatory data and develop accurate, compliant documentation and submission dossiers.
Detail-oriented with strong organizational and problem-solving skills.
Ability to manage multiple tasks including multiple documents preparation/ review, projects, and timelines efficiently in a fast-paced research environment.

About Trial Guna Private Limited:

Trial Guna Private Limited (TGPL) is a Clinical Research Organization (CRO) committed to advancing innovative research solutions. We specialize in conducting high-quality, ethically compliant clinical trials that contribute to the development of effective medical treatments. At TGPL, we foster a dynamic and collaborative work environment that encourages professional growth and excellence.

We look forward to welcoming a dedicated professional to our team who shares our passion for clinical research excellence.

Pay: ₹450,000.00 - ₹500,000.00 per year

Benefits:

Cell phone reimbursement
Flexible schedule
Paid time off
Provident Fund

Work Location: In person

Quick apply

Refine Your Search

regulatory affair jobs in bengaluru karnataka

Regulatory Affairs Associate

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Specialist - Regulatory Affairs - Operations 4A

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Professional II

Regulatory Affairs Manager I

Regulatory Affairs Expert

Principal Specialist, Regulatory Affairs

LifeScience Regulatory Svs Associate

International CMC Regulatory Affairs Manager I

Regulatory Affairs Operations Manager

Specialist- Regulatory Affairs Process Digitalization & AI

RC-REGULATORY COMPLIANCE-Regulatory - SME-Senior Manager

Regulatory Affairs Manager

Senior Regulatory Affairs

Executive - Regulatory Affairs

Senior Regulatory Affairs (RA) Specialist

Learning and Development – Dialysis Training & Clinical Quality

I want to receive the latest job alerts for regulatory affair in bengaluru karnataka

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected