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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$113,325 - $207,763 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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Experience with Agile framework, DevSecOps processes, knowledge of cloud security , GxP, GDPR and other relevant regulatory compliance. At Genmab, we’re committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems.
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Support Acadia’s regulatory systems portfolio including Veeva Vault Submissions, IQVIA RIM Smart, and other utilities and tools used in the management of regulatory information and submission production, partnering with IT, and vendors.
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Reporting to the Director of QA/QC, Regulatory, & Compliance, the Export Regulatory Manager provides oversight of all required documentation related to export, ensuring compliance with all relevant customs regulations.
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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
$90,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Six (6) years of pharmaceutical experience with a broad understanding of pharmaceutical development, Regulatory Affairs, Quality Assurance, Safety and Commercial. The Sr. Manager, Regulatory Affairs Compliance and Planning professional will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget.
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Biostatisticians are individual contributors and report to a GBS Lead. Position ResponsibilitiesDevelops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate.
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A deep understanding of regulatory compliance in pharmaceutical marketing. Maintain strict adherence to regulatory compliance, ensuring all marketing efforts align with industry regulations and ethical standards.
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regulatory job Title: pharmacy Company: Cvs Health Retail in Cranbury, NJ
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