Mobile_menu_button_hd

Senior Regulatory Project Manager, Reg Ops

Ascent

Job Description

DepartmentRegulatory AffairsJob TitleSenior Regulatory Project Manager, Reg OpsHR Job Code  Reports to (Title)Assoc Dir, Regulatory Project Management, Regulatory Affairs OperationsFLSA StatusExemptPosition SummaryThe Senior Regulatory Project Manager is responsible for providing project management support to the growing Regulatory team. This person will utilize Project Management best practices to support major submissions for  and will work on China, US and other regional regulatory filings and across multiple geographies.

Essential Duties & Responsibilities (Primary):
  • 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.
  • 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.
  • Provide project management support for improvement projects that harmonizes RA ways of working across the regions.
  • Responsible for ensuring clarity when preparing meeting minutes.
  • Responsible for maintaining submission timelines.

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 submissions.
.
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
requirementsEducation:
Bachelor's degree required with 5+ years of relevant experience
Masters or MBA a plus
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.)Acknowledgements and approvalsIndividual Acknowledgement: ____________________________________
Printed Name: Date: ____________________Hiring Manager Approval: _______________________________________
Printed Name: Date: ____________________     

Job Requirements

 
Apply
Apply

Job Snapshot

Location US-CA-Oakland
Employment Type Full-Time
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific

Recommended Jobs for You

Privacy Tips

For your privacy and protection, when applying to a job online:

Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.

Terms & Conditions
Snapshot
Ascent
Company:
US-CA-Oakland
Location:
Full-Time
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific
Store Type:

Job Description

DepartmentRegulatory AffairsJob TitleSenior Regulatory Project Manager, Reg OpsHR Job Code  Reports to (Title)Assoc Dir, Regulatory Project Management, Regulatory Affairs OperationsFLSA StatusExemptPosition SummaryThe Senior Regulatory Project Manager is responsible for providing project management support to the growing Regulatory team. This person will utilize Project Management best practices to support major submissions for  and will work on China, US and other regional regulatory filings and across multiple geographies.

Essential Duties & Responsibilities (Primary):
  • 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.
  • 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.
  • Provide project management support for improvement projects that harmonizes RA ways of working across the regions.
  • Responsible for ensuring clarity when preparing meeting minutes.
  • Responsible for maintaining submission timelines.

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 submissions.
.
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
requirementsEducation:
Bachelor's degree required with 5+ years of relevant experience
Masters or MBA a plus
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.)Acknowledgements and approvalsIndividual Acknowledgement: ____________________________________
Printed Name: Date: ____________________Hiring Manager Approval: _______________________________________
Printed Name: Date: ____________________     

Job Requirements

 
Senior Regulatory Project Manager, Reg Ops Apply now