Regulatory Affairs Associate Hiring DDReg Pharma – Gurgaon

Regulatory Affairs Associate Hiring DDReg Pharma – Gurgaon; Gurugram District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

DDReg Pharma in Gurgaon, India is seeking an Associate – Regulatory Affairs (India Market) to drive regulatory submissions, registrations, and lifecycle management across drugs, devices, cosmetics, and nutraceuticals. You will work with CDSCO processes, prepare registration dossiers, and coordinate with stakeholders to ensure timely approvals.

The role requires 3+ years in Regulatory Affairs, familiarity with the Sugam Portal, and strong knowledge of India’s regulatory framework, GMP, and QMS

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline (B Pharm, M Pharm, MSc.)
• 3+ years of experience in Regulatory Affairs, preferably Drugs/Cosmetics/Nutraceuticals/Medical Devices
• Strong understanding of India-specific regulatory guidelines and CDSCO processes

Responsibilities

• Prepare and manage CDSCO submissions for drugs, devices, cosmetics, and nutraceuticals
• Draft and review registration dossiers and licenses
• Manage product lifecycle activities including amendments and renewals
• Coordinate with CDSCO/DCGI for queries and approvals
• Submit applications via Sugam Portal and track timelines
• Maintain multiple licenses and registrations per regulatory requirements
• Ensure compliance with regulations, GMP, and QMS guidelines
• Interact with relevant departments for registrations and permissions

Skills

CDSCO submissions

GMP knowledge

QMS awareness

Regulatory strategy

Education

B Pharm, M Pharm, Life Sciences

Tools

Sugam Portal

Job description

B Pharm, M.Pharm Regulatory Affairs Associate | DDReg Pharma – Gurgaon

Apply for Associate – Regulatory Affairs at DDReg Pharma, Gurgaon. Open for B Pharm, M.Pharm, Life Sciences graduates with 3+ years of experience.

Join DDReg Pharma, a reputed global regulatory consulting firm, as an Associate – Regulatory Affairs (India Market) in Gurgaon. This role offers an exciting opportunity for professionals passionate about pharmaceutical regulations, compliance, and ensuring the highest quality standards in drug, device, and cosmetic approvals. Candidates with strong understanding of CDSCO guidelines and experience with the Sugam Portal are especially encouraged to apply.

Company Overview

DDReg Pharma is a globally recognized regulatory consulting organization specializing in regulatory affairs, pharmacovigilance, and quality compliance solutions. With a strong presence across major pharmaceutical markets, DDReg partners with leading pharmaceutical, medical device, nutraceutical, and cosmetic companies to simplify complex global regulations. The company’s India operations focus on supporting CDSCO submissions, ensuring compliance, and enabling faster access of healthcare innovations to the Indian population.

At DDReg, employees thrive in a knowledge-driven, collaborative environment where regulatory excellence meets innovation. The company is committed to training and development, offering professionals the chance to work on high-impact projects and contribute to the advancement of public health.

Job Role & Responsibilities

As an Associate in Regulatory Affairs (India Market), you will play a key role in ensuring compliance with India’s regulatory framework across pharmaceuticals, medical devices, cosmetics, and nutraceuticals. Your day-to-day tasks will include:

• Preparing and managing CDSCO regulatory submissions for New Drugs, Generics, Biosimilars, Medical Devices, Nutraceuticals, and Cosmetics.
• Drafting and reviewing dossiers for registration and import licenses.
• Handling product lifecycle management including amendments, renewals, and license updates.
• Coordinating with CDSCO/DCGI for query resolution, deficiency responses, and timely approvals.
• Submitting applications via the Sugam Portal and tracking approval timelines.
• Managing multiple licenses and certificates such as CT-06/07/11/13/14/15/17/19/20/22/23/24/25/27, COS-2/4, MD-15/5/9, Form 41, etc.
• Ensuring regulatory compliance with applicable laws, guidance, and standards for import and registration of drugs, medical devices, and diagnostics.
• Interacting with FSSAI and Legal Metrology departments for Nutraceutical product registrations.
• Maintaining up-to-date knowledge of CDSCO regulations, GMP, and QMS practices.

Eligibility / Qualifications

Educational Requirements:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline (B Pharm, M Pharm, MSc. in Life Sciences).

Experience:

• Minimum 3+ years of experience in Regulatory Affairs, preferably within the Drugs, Cosmetics, Nutraceuticals, and Medical Devices sectors.
• Proven track record in handling CDSCO submissions and using the Sugam Portal.

Technical Skills:

• Comprehensive understanding of India-specific regulatory frameworks.
• Experience in dossier compilation, registration documentation, and product lifecycle management.
• Familiarity with GMP and QMS systems.

Soft Skills:

• Strong communication and interpersonal skills.
• Analytical and problem-solving abilities.
• Excellent time management and multitasking.
• Proactive, detail-oriented, and adaptable mindset.

Location & Salary

Location: Gurgaon, Haryana, India.
Employment Type: Full-time.
Salary: Competitive, as per industry standards and experience.

Why Join DDReg Pharma?

• Work with a global regulatory leader that collaborates with top pharma and biotech organizations.
• Gain exposure to multi-category submissions – Drugs, Devices, Nutraceuticals, and Cosmetics.
• Be part of a knowledge-driven team focused on continuous learning and innovation.
• Opportunity to work on diverse regulatory projects and shape India’s healthcare compliance landscape.

FAQs

Q1. What qualifications are required for this role?
A Bachelor’s or Master’s degree in Pharmacy or Life Sciences (B Pharm, M Pharm, MSc.) with at least 3 years of regulatory experience.

Q2. Is experience with the Sugam Portal necessary?
Yes, candidates must be proficient in managing submissions and approvals through the Sugam Portal.

Q3. What kind of regulatory submissions will I handle?
You will work on submissions for Drugs, Medical Devices, Biosimilars, Nutraceuticals, and Cosmetics with CDSCO and related agencies.

Q4. What is the work location?
The position is based in Gurgaon, Haryana, with opportunities to collaborate with national and international clients.