Regulatory Operations 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...

Job ProfileFinancial Operations SpecialistWe seek an experienced Financial Operations Specialist to lead our North India region's financial operations. The successful candidate will be responsible for managing accurate accounting records, preparing financial reports, and ensuring compliance with regulatory requirements.

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...

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...

Pharma IT Operations SpecialistWe are seeking a skilled Pharma IT Operations Specialist to manage our manufacturing plant's IT operations.Ensure alignment with corporate IT standards and regulatory requirements in the manufacturing environment.Provide compliant support for manufacturing systems, including MES, LIMS, SCADA, and ensure proper documentation and...

Regulatory Compliance SpecialistYou will play a pivotal role in ensuring our organization's adherence to all applicable statutory, regulatory, and internal governance requirements.Compliance Audit and Reporting: Conduct thorough reviews, maintain comprehensive documentation, and ensure adherence to regulatory requirements and internal standards.Corporate...

Compliance Operations Support RoleThis position involves providing administrative support to the Compliance team in managing various aspects of compliance operations.Managing correspondence with regulatory bodies, including inward and outward SEBI communications.Tracking and escalating SEBI notifications and disseminating guidelines as needed.Maintaining a...

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 SummaryWe are seeking an expert professional to lead product registration projects in regulated countries.Develop and manage global registration strategies for substances, taking into account the EMEA market.Plan, prepare, and submit substance registration dossiers according to regulatory requirements.Provide strategic advice to business units on...