Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
- Gratuity calculator
  
  Check your gratuity amount
- HRA calculator
  
  Check how much of your HRA is tax-free
- Salary hike calculator
  
  Check your salary hike
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 2K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Add office photos

Employer? Claim Account for FREE

Kumar Organic Products

Compare

3.7

based on 158 Reviews

Video summary

6 Kumar Organic Products Jobs

Regulatory Affairs Executive

Kumar Organic Products Ltd.

3.7

based on 158 Reviews

5-10 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Regulatory Affairs Executive

Kumar Organic Products

posted 2mon ago

Job Role Insights

Fixed timing

Key skills for the job

Pharmacy Software Configuration Management Regulatory Affairs Packaging Risk Management Compliance

+ 2 more

Job Description

Role Overview: As a Regulatory Affairs Executive, you will be responsible for overseeing all regulatory aspects of our company s products and operations. You will ensure compliance with applicable regulations and standards, manage submissions to regulatory authorities, and provide strategic guidance to support the development and commercialization of products.

Key Responsibilities:

Regulatory Compliance: Ensure that the company complies with all relevant regulations, guidelines, and standards applicable to its products and operations. Stay updated on regulatory changes and communicate implications to relevant stakeholders.
Regulatory Strategy Development: Develop and implement regulatory strategies to support the development, registration, and commercialization of products. Work closely with cross-functional teams to align regulatory strategies with business objectives.
Regulatory Submissions: Prepare, review, and submit regulatory filings, including applications, registrations, notifications, and reports, to regulatory authorities. Coordinate responses to queries from regulatory agencies and ensure timely resolution.
Product Development Support: Provide regulatory guidance and support to product development teams throughout the product lifecycle, from concept to post-market activities. Review product labeling, packaging, and promotional materials for compliance with regulatory requirements.
Quality Assurance: Collaborate with quality assurance teams to establish and maintain quality systems that comply with regulatory requirements. Participate in internal and external audits and inspections, ensuring corrective and preventive actions are implemented as necessary.
Risk Management: Identify regulatory risks and develop risk mitigation strategies to ensure compliance and minimize business impact. Proactively assess regulatory implications of new technologies, processes, and business initiatives.
Cross-Functional Collaboration: Work closely with cross-functional teams, including RD, manufacturing, marketing, and legal, to align regulatory activities with business goals and objectives. Communicate regulatory requirements and provide regulatory guidance to support decision-making processes.
Regulatory Intelligence: Monitor regulatory developments, trends, and best practices relevant to the company s products and industry. Provide updates and recommendations to senior management and stakeholders to inform strategic planning and decision-making.

Qualifications and Skills:

Bachelor s degree in a relevant scientific or technical field; advanced degree (e.g., Master s or Ph.D.) preferred.
5+ years of experience in regulatory affairs within the relevant industry (e.g., pharmaceuticals).
In-depth knowledge of regulatory requirements and guidelines, including FDA, EMA, ICH, and other global regulatory agencies.
Strong understanding of product development processes, quality systems, and regulatory submission requirements.
Excellent communication, negotiation, and interpersonal skills.
Proven ability to manage multiple projects simultaneously and work effectively in a fast-paced, dynamic environment.
Strategic thinking, problem-solving, and decision-making skills.
Regulatory affairs certification (e.g., RAC) is a plus.

Working Conditions:

This position typically operates in an office environment.
Occasional travel may be required to attend meetings, conferences, and regulatory agency inspections.

Employment Type: Full Time, Permanent

Read full job description

Prepare for Executive Regulatory Affairs roles with real interview advice