Yelahanka New Town Bengaluru Karnataka Research associate Jobs – 860 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
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XO Health Inc. —Bengaluru, Karnataka
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EY —Bengaluru, Karnataka
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Amazon Dev Center India - Hyderabad - A85 —Bengaluru, Karnataka
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Bain & Co. —Bengaluru, Karnataka
- Full-time
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HR Service Delivery Associate
Accenture —Bengaluru, Karnataka
- Full-time
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Associate Product Manager
MyAdvice —Bengaluru, Karnataka
- ₹12,00,000 - ₹15,00,000 a year
- Full-time
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Accenture —Bengaluru, Karnataka
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Associate
PwC —Bengaluru, Karnataka
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Regulatory Affairs Associate

TrialGuna Pvt Ltd
Bengaluru, Karnataka

Quick apply

Job details

Full-time
₹4,50,000 - ₹5,00,000 a year
12 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

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