Senior Director, Regulatory Submission Management (Hybrid)

Job Description

The Senior Director, Regulatory Submission Management champions functional and cross-functional project and submission management excellence. The incumbent is expected to apply deep subject matter expertise in project and submission management to lead and identify opportunities, shape objectives, and drive execution of key functional and corporate objectives. This role will be responsible for driving timeline risk mitigation and contingency planning.

Key Duties and Responsibilities

• Provide strategic and operational project, submission, and program leadership activities at all stages of the lifecycle (initiation through closeout).
• Drive communication cross-functionally and with senior leaders on project, submission, and program planning topics including timelines, status, risks, and issues.
• Proactively identify roadblocks and/or constraints impacting strategic imperatives or project execution and lead the team through scenario planning activities.
• Partner with governance forums, senior leaders, and/or team lead(s) to align strategy, goals, and milestones with corporate objectives.
• Propose innovative approaches, define process improvements, and advise leaders on opportunities to optimize project results.
• Determine approach and stakeholders for cross-functional decision-making and issue resolution.
• Establish project team operating norms and measure performance.
• Lead and guide the team to efficiently identify and resolve unusually complex project issues and drive resolution to completion.
• Guide the team to prepare necessary reports to drive data‑driven resource, budget, and trade‑off discussions across the GRA function for complex programs.
• Identify resource needs and utilize scalable resourcing approaches, including outsourced models.

Knowledge and Skills

• Advanced knowledge of project and portfolio management principles, options analysis, strategic planning, business case generation, finance, and resource management.
• Experience in implementing and utilizing various outsourcing and support models.
• Leadership experience managing cross-functional teams with the ability to influence teams to prioritize activities and allocate resources.
• Excellent written and oral communication skills, including well-developed presentation skills.
• Strong organizational skills and ability to manage multiple priorities.
• Strong collaboration skills to effectively interact with internal and external stakeholders at all levels.
• General business management knowledge to assess the impact of project decisions on financial and corporate objectives.
• Expertise in global regulatory filing project management.
• Expertise in Global HA submissions, requirements, and guidelines.
• Expertise in supervisory and management responsibilities.
• Ability to drive firm deadlines.

Education and Experience

• Typically requires a Bachelor’s degree in Life Sciences or a relevant field.
• Typically requires 12 years of experience or an equivalent combination of education and experience.
• Experience within the Life Sciences industry or similar.

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On‑Site‑Eligible role, you can choose to work:

1. Hybrid: work remotely up to two days per week; or
2. On‑Site: work five days per week with ad hoc flexibility.

#LI-AR1   #LI-Hybrid

Pay Range

$224,800 – $337,200

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market‑leading benefits to meet our employees wherever they are in their career, financial, family, and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental, and vision benefits to generous paid time off (including a week‑long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k), and much more.

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
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.

#LI-Hybrid

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].

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