Senior Manager, Css Rpl Aspac

**Overall Responsibilities**
- Represent regional regulatory affairs to lead and shape the communication for key projects and critical issues, including but not limited to new product launch/early evaluation strategies, product lifecycle management & process excellence projects, by partnering with local RA, global RA and other functional partners (e.g. commercial, supply chain, quality, deliver, R&D) to ensure regulatory requirements are well understood and relative actions will be taken to secure launch excellence and/or business continuity and compliance;
- As regional DRI, oversee the forecast planning, lead the prioritization and support the execution and issue resolution of regulatory cycle plans in ASPAC by closely collaborating with global RA;
- Keep abreast of knowledge on ASPAC regulations and their evolutions; Support local RA team to assess impacts and make regulatory recommendation to related stakeholders in region and global;
- Regulatory lead for A&D projects for ASPAC and as partner supporting global A&D regulatory WS lead and regional cross functional leads and cluster/countries to define a comprehensive strategy, planning and business goals; Drive and ensure regulatory strategy and planning execution.

**Functional & Technical Competencies**
- Facilitate conversation between global RA and local RA aligned registration plan based on GSM strategy and consolidate AP region markets regulatory annual cycle planning for NPD/NPI and LCM. Support country to fulfill registration requests especially for urgent and critical submissions.
- As a point of contact person, strategically collaborate with regional marketing and region SC on NPI/NPD, LCM submission priority and registration timeline based on alignment with each market and regulatory pathway. Represent regulatory affairs in regional SC S&OP meeting and plan transformation discussion to input regulatory implication.
- Lead process discussion and improvement via using metrics and reports
- Support and provide regulatory assessment and interpret regulatory implication to supply chain to work out scenario plan based on registration lead time, BP/S&OP delivery
- Ensure RPRC compliance capability 100% of time with accurate collaboration with country and MDM partners. Alert & partner to mitigate with regional SC of any changes/disruption across the franchise SC impacting product availability and service reliability due to regulatory causals
- Support and input regulatory insights to support key projects initiated by global or other non-regulatory function in region.
- Lead AP region A&D projects as applicable and ensure global strategy and planning execute in place.

**Leadership Competencies**
- CONNECT by cultivating strong internal partnerships and collaborations through transparent and constructive conversations, contributing to high-performing team in region
- SHAPE by identifying and communicating meaningful risks, taking appropriate action and demonstrating an awareness of the highest standards of quality and compliance.
- LEAD by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions.
- DELIVER by understanding how one’s own work impacts the franchise and use this understanding to make effective decisions and take actions.

**Qualifications**:

- Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration
- Advanced degree in a technical, medical, or business area is desirable
- 10+ years of business experience in regulatory and industry. Solid regulatory knowledge and working experiences to obtain regulatory approval / clearance of new or modified medical devices
- Strong business acumen, understanding of key global business trends
- Strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously
- Proven ability to think strategically and to translate strategic directives into tactical initiatives
- Excellent executive presentation skills, able to communicate complex ideas clearly and concisely and able to respectfully question and or challenges others to think through problems, improvement opportunities, solutions and plans
- Strong leadership skills and technical analytical skills, operates as leader with understanding and appreciation for regional differences
- Relationship management collaboration skills