Manager Regulatory Affairs

Experienced Manager Regulatory Affairs responsible for managing pharmaceutical regulatory submissions, product registrations, and compliance activities across domestic and international markets. Skilled in dossier preparation, regulatory strategy, documentation management, and coordination with regulatory authorities. Adept at ensuring timely approvals and maintaining compliance with pharmaceutical regulations and quality standards.

Roles & Responsibilities

• Manage regulatory affairs and product registration activities efficiently.
• Prepare and review CTD, ACTD, and regulatory submission dossiers.
• Coordinate with regulatory authorities for approvals and compliance matters.
• Ensure compliance with domestic and international pharmaceutical regulations.
• Monitor updates in regulatory guidelines and industry requirements.
• Coordinate with QA, QC, production, and R&D teams for submissions.
• Review packaging, labeling, and artwork for regulatory compliance.
• Handle regulatory queries and deficiency response activities.
• Maintain licenses, registrations, and regulatory documentation accurately.
• Support audits and regulatory inspection readiness activities.
• Develop regulatory strategies for product lifecycle management.
• Monitor submission timelines and approval status regularly.
• Conduct training on regulatory compliance and documentation practices.
• Ensure proper filing and maintenance of regulatory records.
• Support business expansion through timely regulatory approvals.

Adaptis Pharma Private Limited is a pharmaceutical company focused on delivering quality healthcare solutions through pharmaceutical products and specialized healthcare services.

The company is committed to supporting healthcare advancement through innovation, quality assurance, and customer-focused pharmaceutical solutions.

Our Story

Adaptis Pharma Private Limited was established with the vision of contributing to the healthcare industry through reliable pharmaceutical products and ethical business practices.

Over the years, the company has expanded its capabilities and strengthened its market presence by focusing on operational excellence, product quality, and customer trust.

Our Mission

The company aims to:

• Deliver high-quality pharmaceutical and healthcare products
• Maintain strong quality and regulatory compliance standards
• Support better healthcare outcomes through reliable medicines
• Continuously improve operational efficiency and product quality
• Build long-term relationships with customers and healthcare partners

Our Vision

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

Our Services / What We Offer

Adaptis Pharma Private Limited offers a broad range of pharmaceutical and healthcare solutions, including:

• Pharmaceutical product manufacturing and distribution
• Quality-focused healthcare formulations
• Customer-oriented pharmaceutical services
• Reliable healthcare product supply solutions
• Support for diverse healthcare needs

Why Choose Us

The company stands out for its commitment to pharmaceutical excellence:

• Strong focus on quality assurance and compliance
• Customer-centric healthcare approach
• Experienced professionals and operational expertise
• Commitment to innovation and continuous improvement
• Reliable pharmaceutical manufacturing and supply capabilities

Our Team

Adaptis Pharma Private Limited is supported by a team of experienced professionals dedicated to maintaining high standards in manufacturing, quality control, operations, and customer service.

Their expertise contributes to efficient processes and reliable healthcare product delivery.

Infrastructure / Technology

The company utilizes modern infrastructure and advanced operational systems to support efficient pharmaceutical production and quality assurance.

Its facilities are designed to maintain compliance, reliability, and operational efficiency.

Our Commitment

Adaptis Pharma Private Limited remains committed to delivering safe, effective, and high-quality pharmaceutical products while maintaining strong ethical and quality standards.

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