Roche
Pharmaceutical
SeniorGroupDirector,TechnicalRegulatoryAffairs
“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
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