At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
(Sr.) Regulatory Affairs Manager, Dossier Management
YOUR TASKS AND RESPONSIBILITIES
Lead SPT to ensure timely dossier review/compilation and submission with high quality to enable new product approvals.Supervise submission team members to execute aligned registration strategy and ensure readiness of Chinese dossier, including the quality of translation/vendor control, submission preparation progress tracking and key elements’ consistency.Keep building Bayer eCTD capacity by establishing eCTD submission ready infrastructure and process. Continuously drive eCTD fully implementation in China according to CDE policy/guidelines.Assist timely tracking on projects status, identify the potential gap by comparing with the assigned submission timeline and timely inform the supervisor.Leverage digitalization and innovation to develop toolkits and generate process efficiencies, such as AI translation.Make alignment and strong interface with business partners, both internal functions and external publishers. Optimize the cooperation process with RPM in global, TA/CMC teams in GRA China and cross functions in BHC to achieve GRA China’s objective. Proactively support other tasks such as SOP taskforce and regulatory intelligence contribution etc.Visionary that guides the team as needed in defining the outcomes to deliver on the mission.Catalyst that removes roadblocks to facilitate dossier management and submission.Architect that facilitates shaping a value creating system to unleash team’s passion and energy.Coach that helps the team learn and build the capabilities needed to create value for the stakeholders.Acquire capabilities to achieve ways of working supporting our business transformation (e.g. DSO) and figure out the new initiatives from submission aspect to add new value to company. Ensure the internal and external compliance, including internal Sop, system and local regulation, also foresee the potential risk of compliance.
WHO YOU ARE
Demonstrates innovation, strategic thinking and focus on outcomes.Acts, learns fast and evolves as works in 90-days cycles, applies learnings fast and continually develops.Respects differences, embraces inclusion and shows up the openness. Establishing partnerships and working collaboratively with others to meet shared objectives.Graduate level scientific or life sciences background in a relevant area, with at least 6 years of regulatory experience in pharmaceutical industry (CTA/NDA related experience is preferred). Strong communication skills in English and Chinese, building strong customer relationships and delivering customer-centric solutions. Ability to work within a global team framework.Preferably but not must, high expertise on regulatory IT literacy.
YOUR APPLICATION
If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to cnreferral@bayer.com
Location:
China : BeiJing : BeiJing
Division:
Pharmaceuticals
Reference Code:
836981