Senior Manager, Regulatory Affairs Global Submission Management
50 Northern Avenue Boston, MA 02210 US
Job Description
- Soft Skills
- fast paced environment, adaptable, good communicator, management.
- Hard Skills
- conceptual knowledge of types of Global HA submissions, Project Management, regulatory filings, stakeholder management.
- Education
- Bachelor’s degree in life sciences or technology Background
- Experience
- 5+ years in submission management/regulatory affairs
Key Duties and Responsibilities:
- Leads complex project plans from project initiation to closeout.
- Facilitates the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.
- Develops complex project plans, status reports, issue logs, and other project-related artifacts.
- Identifies facilitating strategies for risk mitigation and contingency planning within plan.
- Identifies and resolves complex project plan issues and takes a new perspective on existing solutions.
- Communicates project status, difficult or sensitive issues, schedule and accomplishments to various management and stakeholder groups, as needed, and works to build alignment
- Prepares necessary reports to drive data-driven resource, budget and trade-off discussions across GRA function
- Experience in regulatory filing project management
- Expertise in project management tools
- In-depth conceptual knowledge of types of Global HA submissions and requirements and guidelines
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
- Excellent organization, written/verbal communication, and attention to detail to explain difficult information and works to build alignment
- Stakeholder management skills
- Ability to balance multiple tasks to meet priorities and timelines
- Bachelor’s degree in life sciences or technology area
- Typically requires 6 years of project management experience in regulatory/clinical project management or project management experience in a life sciences company, or the equivalent combination of education and experience
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Boston, MA
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.