Department: Regulatory Affairs
Reports to (Title): Director/Sr. Director, Regulatory Affairs Operations
The Associate Director, Regulatory Project Manager, is responsible for providing project management support to the growing Regulatory team. This person will help to establish the Regulatory Project Management Function at BeiGene and will work on China, US and other regional regulatory filings and across multiple geographies.
Essential Duties & Responsibilities (Primary):
- Ensure the work is evenly distributed across the regions and offices, measure team outputs, offer feedback, and work with project leaders to ensure timely, efficient, and effective moderation of meetings, and to ensure adequate progress on team activities between meetings.
- Collaborate with submission stakeholders to plan major submissions for both the China region and the global roll-out of submissions. Based on these outputs prepare a submission forecast to ensure that the Regulatory team is adequately resourced.
- Identify and propose improvement projects that harmonizes RA ways of working across the regions and establish an educational platform to promote these initiatives.
- Key member of the Regulatory Operations Management team. Work alongside the China & US team to identify, propose, develop and manage improvement projects.
- Direct submission communications and ensures that all submission customers are fully informed and knowledgeable of submission activities and their status.
- Partner with departments outside of Regulatory, who are responsible for the content for a submission, to ensure quality Regulatory submissions are made on time.
- Organize and manage meetings with departments outside of Regulatory to coordinate, plan, and track submissions for Regulatory.
- Responsible for ensuring clarity when preparing meeting minutes.
- Able to articulate complex regulatory project management initiatives and issues at all levels within the Company. Will be expected to provide updates to the multiple stakeholders and customers of the Regulatory Operations team on multiple initiatives.
- Responsible for the planning, tracking and project management of complex to moderately complex regulatory submissions which require interaction with departments outside of Regulatory Operations in line with ICH requirements, China requirements, other regional requirements and scientific and company policies and procedures.
- Responsible for maintaining submission timelines.
- Manage and mentor more junior members of staff on how to create project plans, and develop projects.
Core Competencies, Knowledge and Skill Requirements:
- Experience in leading a team of cross-functional individuals.
- Strategic thinking is required, with a focus on process improvement and optimization.
- Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.
- Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.
- Accountable for their work; shows initiative and leadership, displaying integrity in everything they do, thriving in a team environment, and seeks excellence as the measure of success.
- Experience in managing shifts in/competing priorities or unforeseen challenges, without compromising quality, attention to detail and timeline deliverables while successfully communicating and working with supervisor, team members and customers.
- Experience in working well independently and in a group environment.
- Demonstrated progressively responsible duties in prior positions.
- Familiarity with pharmaceutical development and Regulatory global submissions is a plus.
.Communication & Interpersonal Skills:
- Resilient profile with the ability to deliver in an ambiguous environment
- Ability to engage and manage multiple stakeholders to achieve the objective
- Curious with learning agility
- Operationally excellent
- Organized with systematic approach to prioritization
- Process orientated to achieve the business objective
- Ability to work in fast-changing and developing environment
Bachelor’s degree required with 8+ years of relevant experience
Masters or MBA with 6+ years of relevant experience
- Experience should include 3 years of participation in cross-functional project management activities.
- PMP or similar certification preferred
- Working knowledge with common project management systems required
- 3 to 4 years of prior job experience preferred in a pharmaceutical project management role, working with multi-department/multi-functional teams.
Travel, Physical DEmands and work environment (AS APPROPRIATE FOR THE POSITION):
Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)