CMC Expert, Regulatory
WarszawaCMC Expert, Regulatory
Warszawa
NR REF.: 1159734
Job Purpose:
• Drives strategy for CMC regulatory submissions. Coordinates timely preparation and authors CMC complex technical regulatory dossiers to support applications for marketing authorisation, lifecycle activities and maintenance of registered pharma and vaccines products in accordance with the applicable regulations and scientific standards.
• Identifies risks associated with submission data and information packages. Ensures adequate contribution and leads CMC Regulatory discussions during interactions with regulatory authorities Worldwide.
• Contributes to the creation, maintenance and continuous improvement of CMC Regulatory processes, policies, instructions, and systems.
• Will serve as a mentor/trainer for new team members.
• Acts as Subject Matter Expert.
• Acts as Technical Dossier Approver.
• Ensures adequate interaction and partnership with the Global Regulatory Lead’s team, PSC, QA, LOCs, 3rd Parties in order to define proper regulatory CMC filing strategy.
Key Responsibilities:
• Independently assesses, manages, and/or drives the CMC strategy, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements.
• Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to R&D teams, Quality Control, PSC, QA and LOC.
• Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus.
• Ensures adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions.
• Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities.
• Mentors and/or trains staff, Develop Subject matter experts (SMEs) within team by providing guidance and relevant knowledge.
• Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.
• Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems. Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.
• Communicates, through the appropriate teams, complex regulatory issues across company and with external agencies and third parties as necessary to influence project and policy issues that are aligned with the company business needs ensuring optimum position for the. May represent the company externally (e.g. Audits, Conferences, External Forums).
• Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines.
We offer:
• Remote work (during pandemic)
• After Pandemic - Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)
• Established job in an international, well-known pharmaceutical company
• Opportunity to work in professional team playing crucial role in introducing the company portfolio to the market
• Opportunity to work within company standards and documentation applied globally
• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
• Canteen for employees at site (with discounts)
• Flexible working hours
Warszawa
NR REF.: 1159734
Job Purpose:
• Drives strategy for CMC regulatory submissions. Coordinates timely preparation and authors CMC complex technical regulatory dossiers to support applications for marketing authorisation, lifecycle activities and maintenance of registered pharma and vaccines products in accordance with the applicable regulations and scientific standards.
• Identifies risks associated with submission data and information packages. Ensures adequate contribution and leads CMC Regulatory discussions during interactions with regulatory authorities Worldwide.
• Contributes to the creation, maintenance and continuous improvement of CMC Regulatory processes, policies, instructions, and systems.
• Will serve as a mentor/trainer for new team members.
• Acts as Subject Matter Expert.
• Acts as Technical Dossier Approver.
• Ensures adequate interaction and partnership with the Global Regulatory Lead’s team, PSC, QA, LOCs, 3rd Parties in order to define proper regulatory CMC filing strategy.
Key Responsibilities:
• Independently assesses, manages, and/or drives the CMC strategy, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements.
• Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to R&D teams, Quality Control, PSC, QA and LOC.
• Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus.
• Ensures adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions.
• Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities.
• Mentors and/or trains staff, Develop Subject matter experts (SMEs) within team by providing guidance and relevant knowledge.
• Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.
• Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems. Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.
• Communicates, through the appropriate teams, complex regulatory issues across company and with external agencies and third parties as necessary to influence project and policy issues that are aligned with the company business needs ensuring optimum position for the. May represent the company externally (e.g. Audits, Conferences, External Forums).
• Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines.
We offer:
• Remote work (during pandemic)
• After Pandemic - Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)
• Established job in an international, well-known pharmaceutical company
• Opportunity to work in professional team playing crucial role in introducing the company portfolio to the market
• Opportunity to work within company standards and documentation applied globally
• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
• Canteen for employees at site (with discounts)
• Flexible working hours
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