Job Description
14 month contract
Hybrid or remote working available
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 and 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 and requirements and guidelines
- Ability to drive firm deadlines and adapt quickly to changing requirements and priorities
- Excellent organization, written/verbal communication, and attention to detail to persuade managers and leaders to take action
- Stakeholder management skills
- Ability to balance multiple tasks to meet priorities and 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 and supervisory/management experience, or the equivalent combination of education and experience
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Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
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Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
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Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
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Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
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What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
