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REGULATORY TEAM LEADER (ONCOLOGY)
Job Field: Government Jobs
Location: United States, CA
Salary: $Not stated
Location: United States, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Job ID:00393109Job287of371Regulatory Team Leader (Oncology)South San Francisco, CaliforniaJob factsJob functionClinical Regulatory AffairsLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelManagerServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionPosition Purpose:Provides line management and regulatory leadership to a group of PDR personnel (minimum three) within a Region or Global Franchise within a TA. Serves as a deputy to his/her line manager as necessaryMajor Responsibilities and Accountabilities:* With the EU-ROW/North America Regional Head and Global TA Head, responsible for resource allocation, knowledge sharing processes, people development* Sets the goals for the group members (in line with EU-ROW/North America Regional Head and Global TA Head) and evaluates performance against the goals at mid-year and end of year* Coaches and mentors direct reports* Assists employees in setting priorities when business conflicts arise aligned within Global TA* As needed represents PDR at health authority meetings* Identifies training needs and sets objectives for training sessions, standard practices, SOPs and departmental policies. Ensures employees receive the essential training and mentoring needed to do their jobs.* Drives a culture of excellence for employees to perform at their highest ability* Engages in career development discussions with employee regarding potential opportunities for continued growth and development* Establishes criteria (aligned within Global TA) for hiring new employees in the group and actively participates in the hiring process* Manages human and financial resources for the group* Serves as a deputy to his/her line manager as necessary* Performs major project responsibilities as time permits and/or needed to support deliverables of group and Global TA* Maintains working knowledge of regulatory and scientific areas that impact the group and leverages knowledge when appropriate* Provides guidance, input and strategic regulatory direction and mentorship on projects, risk assessments, critical issue management and regulatory submissions* Maintains and leverages working relationships with key internal stakeholders* Identifies business opportunities and acts as a change agent and role model within PDR by modeling best practices* Serves as part of leadership, management and contribution to peer reviews and other relevant committees* Manages up to one project on either a regional or global basisWho You AreQualifications:* Minimum of 5+ years of direct regulatory experience* Demonstrated regional leadership role* Demonstrated expertise in leading/delivering global and/or regional filings, reviews and approvals of major submissions to Health Authorities such as original IND/CTA/NDA/MAAExperience and/or Competencies Required:* Demonstrated excellence in the core competency areas of leadership, influence management, change management, customer focus/business focus, innovative/creative thinking, job knowledge, interpersonal/communication skills, global teamwork, coaching/mentoring. Specific examples of behaviors supporting these competencies include:* Drives employees toward meetin
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<tr><td valign="top" width="450"><b>Job ID:00393109Job287of371Regulatory Team Leader (Oncology)South San Francisco, CaliforniaJob factsJob functionClinical Regulatory AffairsLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelManagerServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionPosition Purpose:Provides line management and regulatory leadership to a group of PDR personnel (minimum three) within a Region or Global Franchise within a TA. Serves as a deputy to his/her line manager as necessaryMajor Responsibilities and Accountabilities:* With the EU-ROW/North America Regional Head and Global TA Head, responsible for resource allocation, knowledge sharing processes, people development* Sets the goals for the group members (in line with EU-ROW/North America Regional Head and Global TA Head) and evaluates performance against the goals at mid-year and end of year* Coaches and mentors direct reports* Assists employees in setting priorities when business conflicts arise aligned within Global TA* As needed represents PDR at health authority meetings* Identifies training needs and sets objectives for training sessions, standard practices, SOPs and departmental policies. Ensures employees receive the essential training and mentoring needed to do their jobs.* Drives a culture of excellence for employees to perform at their highest ability* Engages in career development discussions with employee regarding potential opportunities for continued growth and development* Establishes criteria (aligned within Global TA) for hiring new employees in the group and actively participates in the hiring process* Manages human and financial resources for the group* Serves as a deputy to his/her line manager as necessary* Performs major project responsibilities as time permits and/or needed to support deliverables of group and Global TA* Maintains working knowledge of regulatory and scientific areas that impact the group and leverages knowledge when appropriate* Provides guidance, input and strategic regulatory direction and mentorship on projects, risk assessments, critical issue management and regulatory submissions* Maintains and leverages working relationships with key internal stakeholders* Identifies business opportunities and acts as a change agent and role model within PDR by modeling best practices* Serves as part of leadership, management and contribution to peer reviews and other relevant committees* Manages up to one project on either a regional or global basisWho You AreQualifications:* Minimum of 5+ years of direct regulatory experience* Demonstrated regional leadership role* Demonstrated expertise in leading/delivering global and/or regional filings, reviews and approvals of major submissions to Health Authorities such as original IND/CTA/NDA/MAAExperience and/or Competencies Required:* Demonstrated excellence in the core competency areas of leadership, influence management, change management, customer focus/business focus, innovative/creative thinking, job knowledge, interpersonal/communication skills, global teamwork, coaching/mentoring. Specific examples of behaviors supporting these competencies include:* Drives employees toward meetin
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