Roche
Pharmaceutical
SeniorGroupDirector,TechnicalRegulatoryAffairs
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“Senior Group Director, Technical Regulatory Affairs at Roche. Skills: Technical Regulatory Affairs, People Management, Regulatory Strategy. Lead a team of China Technical Partners. Accountable for China regulatory CMC submissions”
Industry & Context.
Develop and implement robust end-to-end China filing strategies; Identify regulatory risks and develop migration plans; Extracts optimized business results through skillful collaboration with others; Identifying solutions that will balance the needs of all parties involved; Able to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making
What They're Looking For.
Must Have
8 or more years work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory or related experience, Master’s Degree in life science disciplines
Nice to Have
Post Graduate Degree, Previous People management or cross-functional team leadership experience
What You'll Do.
Lead a team of China Technical Partners
Accountable for China regulatory CMC submissions
Develop and implement China filing strategies
Accelerate drug access and continuous supply
Ensure right first-time submissions
Shape the regulatory environment in China
Manage China Technical Partners
Manage CMC program managers
Set performance objectives
Provide timely feedback
Align development goals
Provide guidance and manage work activities
Lead cross-functional regulatory initiatives
Define critical steps and resources
Implement initiatives and strategies
Communicate with regulatory personnel
Collaborate with management on HA interactions
Make decisions based on cross-functional priorities
Provide leadership to regulatory professionals
Responsible for performance management
Facilitate regular development discussions
Provide coaching and mentoring
Coordinate resources and priorities
Follow up on project progress
Develop submission strategies
Identify regulatory risks
Develop migration plans
Build relationships with stakeholders
Collaborate on technical strategy
Balance regulatory and supply needs
How You'll Work.
Team & Collaboration
Close collaboration with global development teams; Proactive communication with regulatory and cross-functional personnel; Collaboration with management in leading communications with HA; Build and maintain productive and trusted relationships within/across departments; Build and maintain relationships with external partnerships and regulators; Build and maintain relationships between companies and cultures; Proven track record of team leadership; Proven track record of building and sustainable relationships with internal and external partners/stakeholders; Exceptional influencing and negotiation skills; Skillful collaboration with others; Excellent interpersonal and collaboration skills
Communication Scope
Open dialogue; Proactively communicates with regulatory and cross-functional personnel; Collaborates with management in leading communications with HA; Excellent communication and presentation skills; Exhibits professional maturity, confidence and competence; Able to synthesize and summarize complex issues and conclusions
Process & Methodology
Manage CMC program managers, Define associated critical steps and resources needed, Takes responsibility for implementation of these initiatives and strategies, Regularly follow up and check in the progress of every specific project in the team, Outstanding organizational and time management proven ability to work under pressure
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position The people leader leads a team of China Technical Partners (CTPs) and CMC professionals that are accountable for China regulatory CMC submissions, through developing and implementing robust end-to-end China filing strategies based on close collaboration with global development teams, China business priorities, China regulatory requirements and landscape. The scope includes the complete Roche portfolio, the global products (small molecules, biologics, new modalities). The focus of this role is to lead and coach the team members in order to accelerate drug access and continuous supply to the patients by ensuring right first-time submissions to Chinese Health Authorities and effective interactions with the Health Authority. The incumbent of the role is responsible to shape the regulatory environment in China in close collaboration with PTR Policy and translate that into innovative regulatory strategies. In line with Roche’s China strategy and the China First initiative, this is a role with a high business impact. In this position, the people leader is responsible for the management of China Technical Partners (CTPs) and CMC program managers, which includes setting performance objectives, providing timely feedback, and ensuring alignment of short-term development goals with longer-term career goals. Provides guidance and manages work activities of others for specific projects and/or objectives. Demonstrates the fundamentals of effective coaching skills and mentoring. Adapts coaching style to meet
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