Description
Job Location: London, UK
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
General Summary
The Associate Director, Regulatory Submission Management is responsible for the planning, managing and tracking of the regulatory portfolio of submissions across a number of assigned programs. This role will be responsible for driving comprehensive plans and reports that would include all major milestones and other key dates related to the filings. The role will focus on achieving regulatory submission activities and driving the broader GRA team to ensuring all deliverables are met. This role will be responsible for driving timeline risk mitigation and contingency planning.
Key Duties And Responsibilities
- Oversees complex project and portfolio plans from project initiation to closeout.
- Drives the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements.
- Oversees the development of project plans, status reports, issue logs, and other project-related artifacts.
- Leads strategies for risk mitigation and contingency planning within plan. Efficiently identifies and resolves project issues within the team and drives the resolution to completion.
- Manages project status, issues, schedule and accomplishments and communicates to various management and stakeholder groups as needed.
- Leads and manages members of submission management team.
- Leads the preparation of necessary reports to drive data-driven resource, budget and trade-off discussions across the GRA function.
- As a people manager within the organization may have financial accountabilities human resource responsibilities for assigned staff.
Knowledge And Skills
- Expertise in global regulatory filing project management
- Expertise in project management tools
- Comprehensive understanding of types of Global HA submissions requirements guidelines
- Ability to drive firm deadlines adapt quickly to changing requirements priorities
- Excellent organization written/verbal communication attention to detail persuade managers leaders take action
- Stakeholder management skills
- Ability balance multiple tasks meet priorities timelines
- Supervisory/management experience
Education And Experience
Bachelor’s degree in life sciences or technology area Requires project management experience in regulatory/clinical project management or project management experience in a life sciences company supervisory/management experience or equivalent combination education experience
Flex Designation Hybrid - Eligible Or On-Site Eligible
Flex Eligibility Status
In this Hybrid - Eligible role you can choose to be designated as: Hybrid work remotely up two days per week; or select On-Site work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject Vertex’s Policy on Flex @ Vertex Program may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests scientific innovation.Vertex is committed equal employment opportunity non-discrimination all employees qualified applicants without regard person race color sex gender identity expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status any characteristic protected under applicable law.Vertex is an E - Verify Employer United States.Vertex will make reasonable accommodations qualified individuals known disabilities accordance applicable law.Any applicant requiring accommodation connection with hiring process/or perform essential functions position which applicant has applied should make request recruiter hiring manager contact Talent Acquisition at Lifelancer ( https://lifelancer.com ) is talent-hiring platform Life Sciences Pharma IT.The platform connects talent opportunities pharma biotech health sciences healthtech IT domains.For more details find similar roles please check out below Lifelancer link.
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