职位描述
Lead EU regulatory strategy, submissions (MAA/CTA), label discussions, and securing approvals.
Responsible for appropriate Europe Region regulatory input to project teams and regular interface with Global Regulatory Teams.
Makes recommendations to Global Regulatory and drug development teams in order to shape the global strategy in line with regional/commercial objectives.
Own the negotiations with health authorities.
Supports the drug development strategy; defining options for Scientific Advice/Pediatric Investigation Plan, creating briefing packages and co-ordinating and leading agency meetings.
Defines Europe region filing strategy (including CP, MRP, DCP); identifying risks and issues.
Responsible for ensuring effective implementation of filing plan, publishing and archiving of documents.
Responsible for ensuring effective planning, tracking, archiving of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools.
Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance.
Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success.
Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
Lead regulatory process improvements and initiatives.
职位要求
DEGREE & MAJOR: Master’s degree or above, major in biology, medicine or pharmacy related.
Certificate: RAC Europe is preferred.
Professional Knowledge:Previous demonstrated experience of regulatory drug development or equivalent.European regulatory experience.Experience in Oncology is preferred.Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application.
Experience: At least 12 years related working experiences in regulatory affairs.
Skill Requirement:Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.Ability to work strategically within a business critical and high-profile development program.Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.Strong communication skills - both oral and written.
