Company Overview

Sudarshan Consolidated Limited, a prominent name in the Agro chemical manufacturing industry, specializes in the production of surfactants and specialty chemicals for the agrochemical sector, among other industries. Established for over 20 years, the company operates state-of-the-art facilities equipped with advanced R&D and quality assurance systems.

Job Overview

Sudarshan Consolidated Limited is seeking a dedicated Regulatory Manager to join our team in South Delhi. This is a senior-level, full-time position. The successful candidate will ensure compliance with regulatory requirements and lead submissions to regulatory bodies. This role offers an exciting opportunity for an experienced professional to influence both local and international regulatory strategies and implementations within a dynamic and innovative organization.

Qualifications and Skills

• Proven experience in regulatory compliance within the chemical manufacturing industry with an emphasis on ensuring adherence to policies and procedures.
• Expertise in FDA regulations (Mandatory skill) to navigate the complex landscape of compliance and regulatory affairs.
• Proficiency as an international regulatory manager (Mandatory skill) to manage and streamline global regulatory operations.
• Strong background in risk management, allowing for proactive identification and mitigation of potential compliance risks.
• Familiarity with GxP guidelines to ensure good practice across the production and distribution process.
• Experience with CTD/eCTD submissions for efficient handling of electronic regulatory submissions.
• Understanding of ISO standards, contributing to maintaining high-level compliance with applicable certifications.
• Proficient in project management to effectively coordinate and manage regulatory processes and teams.

Roles and Responsibilities

• Develop and implement regulatory strategies to ensure compliance with local and international chemical manufacturing standards.
• Coordinate regulatory submissions, including CTD/eCTD, and maintain a comprehensive database of all registration activities.
• Conduct risk assessments and develop risk management plans to address potential regulatory issues.
• Monitor changes in regulatory legislation and inform management and relevant departments to ensure timely updates to compliance processes.
• Collaborate with R&D, quality assurance, and production teams to verify that all operations comply with GxP guidelines and ISO standards.
• Manage relationships with regulatory authorities to facilitate smooth communication and efficient resolution of regulatory queries or challenges.
• Train and provide guidance to staff on regulatory issues, ensuring awareness and understanding of regulatory requirements throughout the organization.
• Lead and participate in cross-functional project teams to streamline and integrate regulatory knowledge across the company.