Assoc Director, Regional Planning Lead

Assoc. Director, Regional Planning Lead
- Join the **premier biopharmaceutical company **that has been in **AP for over 60 years.**

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Lead manages the regulatory planning of the company regulatory submission targets from a regulatory operational perspective for the whole of the AP region.

As a member of cross-functional team and for the assigned portfolios, he/she will work with his/her team to manage all operational aspects for submission planning and execution of Original Marketing Application (OMA) and post-approval regulatory changes. The core capabilities of Regional Planning Lead include submissions planning as well as the development, implementation, and continuous improvement of business processes related to this area.

The Lead should drive the continued advancement and maturity of regional planning capabilities as well as the continuous improvement of business process and technology to meet stakeholder needs while adapting to a fast-paced regulatory environment

This position requires a high-level expertise and knowledge of the regulatory landscape across the AP Region (including China), its registration procedures and a thorough understanding of the technical requirements for dossiers.

**WHAT YOU WILL DO**
- Responsibilities include, but are not limited to:_

**Primary Activities include but are not limited to**:

- Provide strong, cross-functional team leadership for regulatory submissions within the region and manage senior leader interactions and collaborations.
- Maintain a broad and deep knowledge of all the submission planning activities taking place in his/her assigned portfolio.
- Contribute to the development of regulatory program strategies within the Asia Pacific markets to ensure effective submissions planning & execution.
- Organize and facilitate interactions among submission planners and publishers and Regulatory Liaison roles to align on urgent issues and ensure balanced workload across the region
- Manage regulatory projects from authorization through delivery to country regulatory affairs teams and/or Health Authorities, with a regulatory operations perspective.
- Responsible for developing and maintaining the regulatory submission plan for the assigned key projects/products and maintaining the related project milestones.
- Lead or participate in cross-functional forums and meetings
- Work closely with the central planner based in the HQ (US) on assigned products/projects.
- Drive continuous improvement of business process and technology within the Regional Planning, Regional Publishing team
- Ensure robust functional area oversight of sourced activities to ensure quality, compliance and delivery against key performance criteria.

People Manager for the Regional Planning, team:

- Manage the staff in the Regional Reg Ops Group providing oversight to FTEs, contractors and sourced planning, resources as per business needs.
- Mentor and coach individuals within the department on the concepts, methods and nuances of project management, publishing, and company processes relating to high performing teams, drug development, and regulatory practices.

**WHAT YOU MUST HAVE**

To be successful in this role, you will have:

- Bachelor’s degree in a Life Science related discipline.
- Min of 6-8 years’ experience in Regulatory Affairs with at least 3 years in Regulatory Operations (submissions planning, publishing, etc)
- Leadership:

- Strong people and interpersonal skills to manage effectively across all levels.
- Navigates unfamiliar territory quickly and embraces ambiguity to chart a clear course for the team
- Effective at mentoring and coaching within a team setting
- Demonstrated situational leadership and creative problem solving within organizations and teams
- Partnership:

- Demonstrated strong partnering skills in influencing and negotiating across functions
- Service delivery mindset driven by continual innovation and process improvements
- Demonstrated ability to collaborate, communicate, supervise, and coach across cultures, organizational levels, and disciplines.
- Ability to lead by influence and work effectively in matrix organizational structures
- Excellent communication skills to manage interactions with colleagues in a multicultural environment.
- Regulatory Knowledge & Experience
- Deep understanding of regulatory submission standards, submission procedures and drug development landscape across the Region
- Proven experience in working in and leading cross functional teams to ensure high quality, on-time submissions
- Able to multitask with proven project management capabilities including managing dynami