Regulatory Affairs

Job Description

Job Description Role - Regulatory Affairs Experience - 1 to 3 Years Location- Madhavaram, Chennai Budget - As per the industry Key Responsibilities: 1. Regulatory Submissions: Prepare and submit regulatory documents to authorities for approval, such as new product applications, amendments, and supplements. 2. Compliance: Ensure products meet regulatory requirements, including safety, efficacy, and quality standards. 3. Regulatory Intelligence: Stay up-to-date with changing regulations, guidelines, and industry standards. 4. Risk Management: Identify and mitigate risks associated with products or processes. 5. Collaboration: Work with cross-functional teams, including R&D, Quality, and Manufacturing. 6. Documentation: Maintain accurate and detailed records of regulatory activities, including submissions, approvals, and compliance. Requirements: 1. Education: Bachelor's degree in a relevant field, such as life sciences, pharmacy, or engineering. 2. Experience: Prior experience in regulatory affairs, quality assurance, or a related field. 3. Knowledge: Strong understanding of regulatory requirements, guidelines, and industry standards. 4. Communication: Excellent written and verbal communication skills. 5. Analytical: Ability to analyze complex regulatory information and identify key issues. Skills: 1. Regulatory writing: Ability to write clear, concise, and compliant regulatory documents. 2. Project management: Ability to manage multiple projects and prioritize tasks effectively. 3. Attention to detail: Strong attention to detail and ability to ensure accuracy and compliance. 4. Collaboration: Ability to work effectively with cross-functional teams and build strong relationships. Certifications: 1. RAC (Regulatory Affairs Certification): A certification offered by the Regulatory Affairs Professionals Society (RAPS) that demonstrates expertise in regulatory affairs. Overall, a Regulatory Affairs professional plays a critical role in ensuring compliance with regulatory requirements and facilitating the development and approval of products. Show more Show less