Regulatory Affairs Manager

Job Description

Role & responsibilities Regulatory Compliance: Ensure the companys products and operations comply with all applicable regulatory requirements, including those from governmental bodies and other regulatory agencies. Product Registration & Approvals: Manage the preparation and submission of regulatory dossier for new products and modifications to existing products. This includes product registrations, safety data sheets (SDS), regulatory filings, and other required submissions. Regulatory Strategy & Guidance: Develop and implement regulatory strategies to support product development, marketing, and market entry, while minimizing risk and ensuring full compliance with regulations. Monitoring and Reporting: Stay updated on current and upcoming regulatory changes and communicate impacts to the business. Provide detailed analysis and recommendations on any new or changing regulations that affect product lines, manufacturing, and distribution. Cross-functional Collaboration: Work closely with R&D, Quality, Production, and Legal teams to ensure regulatory considerations are integrated into product development, process improvement, and safety initiatives. Regulatory Audits & Inspections: Coordinate and lead internal and external audits to assess regulatory compliance, ensuring that all necessary corrective actions are taken in a timely manner. Documentation Management: Maintain comprehensive and accurate regulatory files, including product data, approvals, testing protocols, and communication with regulatory bodies. Customer/Stakeholder Communication: Act as a point of contact for regulatory inquiries from customers, suppliers, and external regulatory bodies. Provide guidance on regulatory matters and support the commercial team in meeting customer requirements. Skills & Competencies required: Technical Knowledge: Strong understanding of domestic and international chemical regulations Skills : Excellent written and verbal communication skills Strong analytical and problem-solving abilities Ability to work effectively in a cross-functional team environment Detail-oriented with a commitment to high-quality work Ability to manage multiple priorities and meet deadlines Other Requirements: Proficiency in regulatory compliance software and Microsoft Office Suite Strong organizational skills and ability to handle complex regulatory issues Ability to travel as required for audits and inspections Academic & Professional Qualifications: Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Environmental Science, or a related field. Certification in regulatory affairs (e.g., RAC) is a plus. interested candidates can apply at preeti.sharma@intech.in