Job Overview

Sudarshan consolidated Limited is seeking a Senior Regulatory Affairs professional for our South Delhi location. This full-time role is an excellent opportunity for a seasoned expert to guide the regulatory affairs strategy within the chemical manufacturing industry. The ideal candidate will be instrumental in ensuring compliance across various chemical applications while aligning closely with industry standards.

Qualifications and Skills

• Experience in risk management in regulatory affairs is mandatory for identifying and mitigating regulatory risks. (Mandatory skill)
• Proven expertise in developing regulatory strategies that align with business objectives and industry standards. (Mandatory skill)
• In-depth understanding of regulatory processes specific to agrochemical industries. (Mandatory skill)
• Comprehensive knowledge of the FDA submission process to ensure timely and accurate regulatory submissions.
• Ability to ensure labeling and advertising compliance in accordance with current regulations and industry standards.
• Strong familiarity with EU MDR and IVDR, focusing on compliance with European regulations.
• Skillful in using the Electronic Common Technical Document (eCTD) for efficient document management.
• Experience working with Quality Management Systems (QMS) to uphold quality standards and regulatory compliance.

Roles and Responsibilities

• Develop and implement regulatory strategies to ensure compliance with local and international regulations for chemical manufacturing.
• Lead risk management initiatives to identify, assess, and mitigate regulatory risks associated with chemical products.
• Collaborate with R&D, quality assurance, and manufacturing teams to align regulatory processes with business goals.
• Prepare and review regulatory submissions to the FDA and other international regulatory bodies, ensuring accuracy and timeliness.
• Oversee the compliance of labeling and advertising practices within the organization.
• Manage compliance with EU MDR and IVDR requirements for the company's diverse chemical products.
• Facilitate the preparation, submission, and maintenance of regulatory documents using eCTD systems.
• Ensure the effectiveness of Quality Management Systems by regularly auditing and reviewing compliance procedures.