Senior Officer Regulatory Affairs

The Senior Officer – Regulatory Affairs will be responsible for preparing, reviewing, and coordinating regulatory dossiers and submissions for pharmaceutical products. The involves ensuring compliance with regulatory guidelines, managing product lifecycle activities, handling regulatory communications, and coordinating with cross-functional teams for timely approvals and submissions. The candidate will play a key in maintaining regulatory compliance and supporting business growth through efficient regulatory operations.

Roles & Responsibilities:

• Prepare, review, and compile regulatory dossiers and submission documents for domestic and international markets.
• Manage product registrations, renewals, variations, and regulatory approvals.
• Ensure compliance with regulatory guidelines, pharmaceutical standards, and applicable laws.
• Coordinate with QA, QC, R&D, production, and packaging teams for regulatory documentation and inputs.
• Review technical documents, product data, labeling, and artwork for regulatory compliance.
• Handle regulatory queries, deficiency responses, and communication with regulatory authorities.
• Support preparation and submission of CTD/eCTD dossiers and related regulatory filings.
• Monitor submission timelines and ensure timely completion of regulatory activities.
• Maintain accurate regulatory records, databases, and document tracking systems.
• Ensure compliance of packaging materials, labeling, and promotional content with regulations.
• Participate in audit and inspection readiness activities related to regulatory affairs.
• Coordinate with international agents, distributors, and partners for regulatory requirements.
• Support lifecycle management activities for existing products and product variations.
• Monitor changes in regulatory requirements and assess their impact on products and operations.
• Ensure proper document control and data integrity practices are maintained.
• Assist in new product launch activities from a regulatory perspective.
• Prepare MIS reports, submission trackers, and status updates for management review.
• Support cross-functional coordination for timely execution of regulatory projects.
• Ensure confidentiality and accuracy of regulatory information and submissions.
• Stay updated with current pharmaceutical regulations, guidelines, and industry trends.

Kilitch Drugs is a pharmaceutical company engaged in the manufacturing and distribution of pharmaceutical formulations and healthcare products.

The company is committed to delivering high-quality medicines and healthcare solutions while maintaining strong standards of quality, safety, and regulatory compliance.

Our Story

Kilitch Drugs was established with the vision of contributing to the healthcare sector through reliable pharmaceutical manufacturing and customer-focused services.

Over the years, the company has expanded its operations and strengthened its presence in domestic and international markets by focusing on quality, innovation, and operational excellence.

Our Mission

The company aims to:

• Deliver high-quality and affordable pharmaceutical products
• Maintain strict adherence to quality and regulatory standards
• Continuously improve manufacturing processes and product offerings
• Build long-term relationships with customers and stakeholders
• Support better healthcare outcomes through reliable medicines

Our Vision

To be a globally recognized pharmaceutical company known for quality manufacturing, innovation, and excellence in healthcare solutions.

Our Services / What We Offer

Kilitch Drugs offers a broad range of pharmaceutical products and services, including:

• Manufacturing of pharmaceutical formulations
• Production and distribution of healthcare products
• Quality-focused pharmaceutical solutions
• Domestic and international pharmaceutical supply capabilities

Why Choose Us

Kilitch Drugs stands out for its commitment to pharmaceutical excellence:

• Strong focus on quality assurance and compliance
• Modern manufacturing systems and operational capabilities
• Experienced professionals and industry expertise
• Commitment to innovation and continuous improvement
• Customer-centric approach to healthcare solutions

Our Team

The company is supported by a team of skilled professionals dedicated to maintaining high standards in production, quality control, operations, and customer service.

Their expertise ensures the consistent delivery of reliable pharmaceutical products.

Infrastructure / Technology

Kilitch Drugs utilizes advanced manufacturing facilities and modern technologies to support efficient pharmaceutical production and quality assurance.

Its infrastructure is designed to meet regulatory requirements and maintain high operational standards.

Our Commitment

Kilitch Drugs remains committed to delivering safe, effective, and high-quality pharmaceutical products while maintaining ethical business practices and customer trust.

The company continuously works toward innovation, operational excellence, and improving healthcare accessibility.