6 Regulatory Review Jobs

Key Responsibilities: Provide legal advice on business transactions, contracts, and compliance matters Draft and review legal documents, contracts, and agreements Ensure legal compliance with applicable regulations, including IP, labor laws, and data protection Required Qualifications: 3+ years of experience in legal counsel or corporate law Expertise in commercial contracts, IP law, and data privacy regulations Strong communication and negotiation skills

As a Bcom or Law Fresher, you have the opportunity to join Socradamus Capital Private Limited for a role that provides exposure to Due Diligence and Valuations. Your role will require strong communication skills, analytical abilities, and attention to detail. Key Responsibilities: - Conduct detailed due diligence on AIFs, examining legal and operational aspects. - Analyze fund structures, investment strategies, performance metrics, and compliance documentation. - Prepare comprehensive reports with key recommendations for internal and client review. - Evaluate fund compliance with SEBI regulations and other laws. - Provide valuation support from project concept to commissioning stage. - Assis...

Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA, and Health Canada guidelines. Familiarity with API DMF review based on complete USFDA regulatory requirements. Profound understanding of Solid oral dosage form, Sterile dosage form, complex dosage form, topical-Inhalation dosage form, including manufacturing processes and key regulatory aspects. Ability to evaluate dynamic change cases in relation to ICH Quality/post-approval USFDA guidance. Proficiency in Post-approval submission guidelines and procedures for Annual report/CBE 0/CBE 30 and PAS filling. Responsible for finalizing the Annual Report with the necessary submission data p...

Regulatory Consultant (EU OTC) Responsibilities: Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Prepare cover letter, application form and relevant Module 1 documents for variations. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents...

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as deliver...

Regulatory Oversight: 1. Ensure compliance with employment laws, regulations, and organizational policies. 2. Monitor changes in labor laws and update policies accordingly. Policy Development: 3. Frame, Develop, implement, and maintain HR policies and procedures that reflect best practices and legal standards. 4. Regularly review and update compliance-related documents. Training and Awareness: 5. Conduct compliance training programs for employees. Compliance Audits: 6. Plan and execute internal audits to assess adherence to compliance policies. 7. Identify areas for improvement and implement corrective actions. Investigations: 8. Lead investigations into compliance-related complaints or viol...