Regulatory Project Lead Specialist

Regulatory Compliance SpecialistDescription:We are seeking a highly skilled Regulatory Compliance Specialist to support end-to-end submissions for global markets.The ideal candidate will have experience in managing initial submissions, variations, and full lifecycle management deliverables for the global markets. They will be responsible for preparing...

Our goal is to hire individuals who demonstrate the highest standards of integrity, showcase professionalism in every interaction, treat others with respect and consistently align their personal ambitions with the collective goals of the organization.**Job Description:**The Senior Regulatory Specialist will play a senior role within the Financial Regulatory...

Regulatory Operations SpecialistThis role requires a detail-oriented and experienced Regulatory Reporting professional to execute strategic initiatives.Conduct thorough product audits and compliance checks to ensure adherence to regulatory standards.Implement and monitor daily regulatory compliance requirements.Develop and maintain robust internal control...

Job Description:As a Senior Regulatory Affairs Specialist, you will lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Key Responsibilities:Manage the compilation and submission of Annual Reports, amendments, and deficiency responses to ensure compliance with regulatory requirements.Collaborate with...

Clinical Study SpecialistTransforming complex scientific data into regulatory compliant documents is a key responsibility in this role. Documents such as protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Clinical Study Reports (CSRs) require high-quality development to drive drug development and...

Regulatory Affairs SpecialistWe are seeking a detail-oriented Regulatory Affairs specialist to support end-to-end submissions for global markets.Key Responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.Contribute to Lifecycle Management activities by helping to compile and...

Job Title: IT Project ManagerWe are seeking an experienced professional to oversee the entire project lifecycle, from planning and execution to rollout and post-implementation support.The ideal candidate will possess a strong background in IT Project Management with 5-10 years of experience and exceptional knowledge in demand management.Key responsibilities...

Job OverviewA leading organization is seeking a seasoned IT project lead with expertise in Product Lifecycle Management (PLM) to spearhead a critical global Windchill v13 upgrade initiative. This strategic program will drive business transformation and enhance compliance within the healthcare and life sciences industry.The successful candidate will possess a...

Job Role:We are seeking a dedicated Regulatory Compliance Specialist to lead the implementation of our Quality Management System (QMS) and ensure our products meet quality, safety, and regulatory standards.Key Responsibilities:Develop and execute strategies for ensuring adherence to relevant medical device regulations for market entry and ongoing...

Job Title: Senior Compliance Specialist\Location: Gurgaon, India\Job Type: Full-Time\About Us:\We are a fast-growing organization committed to delivering excellence in regulatory and financial services.\Key Responsibilities:\\Ensure timely filings and compliance including AOC-4, MGT-7A, Form 8, Form 11, and DPT-03.\Handle matters related to share capital...