Ontop Hiring Regulatory Affairs Executive / Sr. Executive

Meta Title: BPharm MPharm RA Jobs Delhi 6-10 Years OSD

Meta Description: B.Pharm, M.Pharm candidates apply for Regulatory Affairs roles in Delhi with 6–10 years experience in CDSCO & ROW markets.

A leading pharmaceutical company is actively hiring Regulatory Affairs (RA) Executive / Senior Executive professionals for its Delhi Head Office. This is a high-impact opportunity for experienced candidates with 6–10 years of expertise in regulatory submissions, dossier preparation, and lifecycle management across OSD (Oral Solid Dosage) and external preparations.

In today’s highly regulated pharmaceutical landscape, regulatory affairs professionals play a critical role in ensuring timely product approvals, compliance with global standards, and seamless market expansion. With increasing demand for regulatory affairs jobs, CTD dossier jobs, CDSCO approval roles, and global pharma compliance careers, this opportunity provides strong exposure to both Indian and international regulatory frameworks.

High CPC keywords such as pharmaceutical regulatory affairs jobs, CTD/ACTD submission, CDSCO approvals, WHO-GMP compliance, eCTD publishing, and global regulatory documentation are strategically embedded to maximize SEO visibility and AdSense revenue.

Company Overview

The hiring organization is a fast-growing pharmaceutical company with a strong footprint in domestic and international markets. The company focuses on high-quality formulations, regulatory compliance, and global product registrations across multiple geographies.

With increasing expansion into ROW (Rest of World) markets such as Africa, CIS, LATAM, Southeast Asia, and other regulated regions, the organization is strengthening its regulatory affairs team to manage complex submissions and ensure compliance with evolving global guidelines.

The company offers a dynamic, compliance-driven environment where professionals gain exposure to real-time regulatory challenges, international filings, and strategic product lifecycle management.

Job Role & Responsibilities

Regulatory Affairs Executive / Sr. Executive

• Preparation and submission of CTD and ACTD dossiers (Modules 1–5) for domestic and international markets
• Handling new product registrations and license renewals with CDSCO and State FDA authorities
• Managing Post-Approval Changes (PAC), including variations, amendments, renewals, and lifecycle updates
• Liaising with regulatory authorities for approvals, COPP issuance, and compliance-related queries
• Compilation and submission of regulatory dossiers for ROW markets (Africa, CIS, LATAM, SEA)
• Review of labeling, artworks, pack inserts, stability data, and validation documentation
• Ensuring compliance with Drugs & Cosmetics Act, WHO-GMP guidelines, and international regulatory standards
• Supporting regulatory inspections, audits, and readiness activities
• Performing gap analysis and regulatory strategy planning for new product filings
• Coordinating with cross-functional teams including QA, QC, Production, and R&D for documentation and submission readiness

This role is central to ensuring successful product approvals, maintaining regulatory compliance, and supporting global market expansion strategies.

Eligibility / Qualifications

Educational Qualification

• B.Pharm, M.Pharm, M.Sc (Regulatory Affairs preferred)
• Relevant Courses: Regulatory Affairs, Pharmaceutics, Pharmaceutical Analysis, Industrial Pharmacy, Quality Assurance, Drug Regulatory Affairs

Experience Required

• 6 to 10 years of experience in pharmaceutical regulatory affairs

Key Skills

• Strong expertise in CTD/ACTD dossier preparation and submission
• Hands-on experience with CDSCO and State FDA processes
• Knowledge of Post-Approval Changes (PAC) and lifecycle management
• Understanding of WHO-GMP and global regulatory frameworks
• Exposure to ROW markets (Africa, CIS, LATAM, SEA)
• Regulatory writing, documentation, and submission skills
• Excellent coordination, communication, and liaisoning abilities

Location & Salary

• Location: Delhi (Head Office)
• Salary: Competitive salary package (estimated ₹8–18 LPA based on experience and expertise)

Application Process

Interested candidates can apply by sending their updated CV along with current and expected CTC to:

• Email: akhilesh.kumar@ontoppharma.com

Ensure the subject line mentions: “Application for Regulatory Affairs Executive / Sr. Executive”.

Why This Opportunity Stands Out

• Exposure to global regulatory markets and international submissions
• Opportunity to work on CTD/eCTD dossiers and lifecycle management
• High-growth domain with strong salary progression
• Strategic role impacting product approvals and compliance
• Work closely with regulatory authorities and global teams

Career Scope in Regulatory Affairs (SEO Boost Section)

Regulatory Affairs is one of the most critical and high-paying domains in the pharmaceutical and biotechnology industry. Professionals in this field ensure that drugs and medical products comply with all regulatory requirements before reaching the market.

With increasing global drug approvals and stricter compliance requirements, expertise in CTD/eCTD submissions, CDSCO regulations, and ROW market filings is highly valuable. Regulatory professionals often transition into leadership roles such as Regulatory Affairs Manager, Global RA Lead, Compliance Head, or Dossier Specialist.

This field offers excellent long-term growth, international exposure, and strong financial rewards.

Key Skills Required for Regulatory Affairs Professionals (SEO Boost Section)

• CTD / ACTD / eCTD dossier preparation
• CDSCO submission and approval handling
• Regulatory lifecycle management (PAC, variations)
• WHO-GMP and international compliance knowledge
• Labeling and artwork review
• Regulatory documentation and audit support
• Coordination with global regulatory agencies

FAQs

Who can apply for this Regulatory Affairs role?

Candidates with B.Pharm, M.Pharm, or M.Sc and 6–10 years of RA experience can apply.

What markets will I be working on?

India and ROW markets including Africa, CIS, LATAM, and Southeast Asia.

What is the key requirement for this role?

Hands-on experience in CTD/ACTD submissions, CDSCO filings, and lifecycle management.

What is the salary range?

Estimated salary ranges between ₹8–18 LPA depending on experience.

How can I apply?

Send your updated CV to akhilesh.kumar@ontoppharma.com.

Additional SEO Titles

• Regulatory Affairs Jobs in Delhi for Experienced Pharma Professionals
• CTD ACTD Dossier Jobs with CDSCO Experience Required
• Pharma Regulatory Jobs for BPharm MPharm Candidates India

Summary Table

Category	Details
Company	Ontop Pharma (Hiring Organization)
Vacancies	Regulatory Affairs Executive / Sr. Executive
Required Education	B.Pharm, M.Pharm, M.Sc (Regulatory Affairs, Pharmaceutics, QA)
Experience	6–10 Years