B Pharm, M Pharm Regulatory Associate Vacancy – DDReg Pharma

B.Pharm/M.Pharm Regulatory Associate Vacancy – DDReg Pharma Gurgaon

Apply now for Regulatory Associate role at DDReg Pharma Gurgaon. Open for B.Pharm/M.Pharm graduates with regulatory affairs expertise. Full-time.

DDReg Pharma, a trusted global regulatory affairs consultancy, is inviting applications for the role of Regulatory Associate at its Gurgaon office. This is a full-time opportunity for qualified professionals passionate about pharmaceutical regulatory compliance and international submissions.

Company Overview

DDReg Pharma is a leading global regulatory affairs solutions provider with a strong footprint in Europe, the UK, WHO, and emerging markets. The company specializes in regulatory submissions, lifecycle management, CTD/eCTD dossier preparation, compliance support, and end-to-end regulatory consulting. With its client-centric approach and technical excellence, DDReg has built a reputation for delivering high-quality regulatory services to top pharmaceutical companies worldwide.

Job Role & Responsibilities

As a Regulatory Associate at DDReg Pharma, you will be responsible for supporting regulatory submissions and managing the lifecycle of pharmaceutical products across global markets. Key responsibilities include:

• Regulatory Compliance & Lifecycle Management: Preparation of variation and requalification dossiers. Ensuring compliance for EU, UK, WHO, and other international submissions.
• CTD/eCTD Sequence Review: Performing Level-1 review of CTD/eCTD sequences for DKT, FHI, and BO submissions. Maintaining quality and productivity standards.
• Query Handling & Documentation: Drafting clear and compliant responses to regulatory authorities and submitting them on time.
• File Preparation & Publishing: Managing electronic publishing activities such as hyperlinking, bookmarking, formatting, and redactions with high technical accuracy.
• Artwork & Labeling Review: Reviewing annotated artwork and comparative labeling texts to ensure consistency and compliance.
• Project Tracking & Documentation: Updating regulatory trackers, product history logs, and task planners to support reporting and accountability.
• Team Collaboration & Communication: Coordinating with internal teams and external clients for smooth communication and timely deliverables.

Eligibility / Qualifications

To apply for this role, candidates should meet the following criteria:

• Educational Qualification: B.Pharm, M.Pharm (Bachelor of Pharmacy, Master of Pharmacy)
• Key Skills:
  • Strong understanding of CTD/eCTD submissions
  • Knowledge of EU, WHO, and emerging market regulatory guidelines
  • Excellent analytical and problem-solving skills
  • Strong communication and interpersonal skills
  • Ability to manage multiple projects with attention to detail
• Soft Skills:
  • Time management and multitasking
  • Positive, adaptable, and collaborative attitude

Location & Salary

• Location: Gurgaon, Haryana (Office-based)
• Employment Type: Full-time
• Salary: As per industry standards (competitive pay with growth opportunities)

Application Process

Interested candidates can apply online through the official DDReg Pharma job portal:
👉 Apply Here

Early applications are encouraged to secure your spot.

Why Join DDReg Pharma?

• Opportunity to work with a global leader in pharmaceutical regulatory consulting.
• Gain exposure to EU, UK, WHO, and emerging markets submissions.
• Work in a collaborative, knowledge-driven environment.
• Career growth opportunities in regulatory affairs and compliance.

FAQs

Q1. Who can apply for this Regulatory Associate role?
Candidates with B.Pharm or M.Pharm qualifications and knowledge of regulatory affairs processes such as CTD/eCTD submissions are eligible.

Q2. Is prior experience required?
Relevant regulatory affairs experience is preferred, though motivated freshers with strong knowledge may also be considered.

Q3. What is the job location?
The position is based at DDReg Pharma’s Gurgaon office, with full-time onsite requirements.

Q4. What markets will I be working with?
You will primarily handle submissions for EU, UK, WHO, and other emerging markets.

Q5. How do I apply?
Applications can be submitted through the official job portal.

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