regulatory jobs in Moderna

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Be a site expert. Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully Effectively manage resources to ensure business priorities are met. Mentor and develop their team. MS/PhD degree in a scientific/engineering discipline 10+ years of experience in the pharmaceutical/biotech industry 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions Strong knowledge of current US, EU, and ROW regulations Strong experience with CTD format and content regulatory filings Exceptional written and oral communication MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 8+ years of experience in Biologics focused Regulatory CMC", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309253642161", "isPrivate": false}, {"id": 309256890491, "name": "(Fixed-Term) Specialist, Regulatory Operations", "location": "Warsaw - Poland", "locations": ["Warsaw - Poland"], "hot": 0, "department": "Regulatory", "business_unit": "Stephen Hoge", "t_update": 1701574680, "t_create": 1700179200, "ats_job_id": "R14718", "display_job_id": "R14718", "type": "ATS", "id_locale": "R14718-en", "job_description": "Work collaboratively with a local team member to provide central data processing for the Global Regulatory Sciences team, supporting the following processes: Archiving Health Authority Correspondences within Veeva RIM Library. Capture Health Authority Questions (HAQs) and generate Response Documents within Veeva RIM. Capture Commitments within Veeva RIM. Create and manage Registrations within Veeva RIM. Create and manage Regulatory Objectives within Veeva RIM. Provide ad hoc data entry requests in Veeva RIM. Provides system support and training to end users. Work collaboratively with International Regulatory Operations to support the following international data processes: Manage IDMP data and submissions. Manage EudraVigilance product data. Participate on special projects: Provide ad hoc data remediation as needed in Veeva RIM. Participate in system enhancement projects as needed. Provide end-user support as needed.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256890491", "isPrivate": false}, {"id": 309256606197, "name": "Sr. Manager Regulatory Strategy", "location": "Toronto - Canada", "locations": ["Toronto - Canada"], "hot": 0, "department": "Regulatory", "business_unit": "Jerh Collins", "t_update": 1701575190, "t_create": 1699228800, "ats_job_id": "R14647", "display_job_id": "R14647", "type": "ATS", "id_locale": "R14647-en", "job_description": "Develop and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including Health Canada meeting requests, CTAs, New Drug Submission (NDSs), Supplemental New Drug Submissions (SNDSs), and other post-NOC submissions. Work with Global Regulatory Science and global cross-functional project teams to develop and execute regulatory strategy from clinical development through to post-marketing activities, ensuring effective communication to define content, timelines and approvals for regulatory submissions. Responsible for coordinating regulatory submissions relevant to assigned projects or programs. Health Canada contact relevant to assigned projects or programs, as appropriate. Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (CTA through commercial). Maintain Canadian labelling (Product Monograph, Artwork) in alignment with global labeling. Ability to work both independently and within project teams to achieve group goals. Accountable for tracking, actioning, and archiving correspondence, regulatory commitments and queries from Health Canada. Assist in the development and maintenance of company-wide and departmental processes, policies, and SOPs. Help keep cross-functional team members apprised of new Canadian regulations, standards, policies and guidances. BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred. 5+ years of experience in the pharmaceutical industry. 3+ years of experience in Regulatory Affairs Experience in the regulation of biologics or vaccines is strongly preferred. Strong knowledge of current Canadian regulations. Food & Drug Act and regulations (F&DA) Good Clinical and Manufacturing practice (GCP/GMP) PAAB Code of Advertising Acceptance Health Canada policies, guidelines, and forms; ICH guidelines Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Strong experience with CTD format, including preparation of Module 1 documents. Exceptional written and oral communication and willingness to share knowledge and lessons learned. Demonstrate strong organizational skills, including the ability to prioritize workload and manage multiple projects in a fast-paced environment. Advanced problem-solving ability and a drive to generate compliant regulatory solutions prior to elevation of topics to manager. A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256606197", "isPrivate": false}, {"id": 309256480166, "name": "Associate Director, Global Regulatory Science, CMC", "location": "Basel - Switzerland", "locations": ["Basel - Switzerland"], "hot": 0, "department": "Regulatory", "business_unit": "Stephen Hoge", "t_update": 1701574656, "t_create": 1698364800, "ats_job_id": "R14612", "display_job_id": "R14612", "type": "ATS", "id_locale": "R14612-en", "job_description": "Develop/implement effective CMC regulatory strategies for International submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide guidance for regulatory CMC aspects of product development projects Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions Develop regulatory processes and procedures to support CMC components of regulatory submissions Support the creation and maintenance of CMC submission templates Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls Provides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required. MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 8+ years of experience in Biologics focused Regulatory CMC", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256480166", "isPrivate": false}, {"id": 309256480171, "name": "(Fixed-Term) Sr. Manager, Global Regulatory Science, CMC", "location": "Basel - Switzerland", "locations": ["Basel - Switzerland"], "hot": 0, "department": "Regulatory", "business_unit": "Stephen Hoge", "t_update": 1701574966, "t_create": 1698364800, "ats_job_id": "R14613", "display_job_id": "R14613", "type": "ATS", "id_locale": "R14613-en", "job_description": "Supports and contributes to the development of effective CMC regulatory strategies for submissions (e.g. CTA/MAA/Variations) and identify regulatory risks associated with the EMA and International Health Agency requirements. Work with Director- Reg-CMC-International, and Global Regulatory Teams regarding the development and execution of regulatory CMC strategies in the EU and International countries Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs Provides guidance for regulatory CMC aspects of product development projects concerning EU and International country regulations. Reviews documents for submission-readiness, to ensure that all submissions conform to health authority guidelines in the EU and International countries Supports CMC change controls related to the EU and International regulations. Provides interpretation of EU/International regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs Contributes to the assessment regulatory risks for assigned projects or programs Ability to work both independently and within project teams, committees, etc. to achieve group goals Prepare and deliver effective communications and presentations for external and internal audiences Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD) 5+ years of experience in the Pharmaceutical industry. 3+ years of experience in Regulatory CMC Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC development Strong experience with CTD format and content regulatory filings Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements Ability to work independently to manage multiple projects in a fast-paced environment Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Project Teams and senior management, as relevant Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256480171", "isPrivate": false}, {"id": 309255247462, "name": "Manager, Regulatory Strategy, International", "location": "Basel - 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