Director, Regulatory Strategy Planning & Operations

Regeneron Pharmaceuticals•Warren, MI

2d•Hybrid

About The Position

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director to join our Regulatory Strategy Planning & Operations team. This role resides in the Global Development area of Regulatory Affairs, Global Patient Safety and Development Quality (RA, GPS & DQ). The Director of Strategy Planning & Operations will work closely with the Senior Director, the broader Strategy Planning & Operations team, the RA, GPS & DQ Leadership Team (LT), and the administrative team to support functional operations and strategic priorities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

10+ years of pharmaceutical or biotechnology industry experience, including planning and operations experience within a global development organization, with demonstrated experience providing strategic oversight, coordination, and operational leadership across cross-functional teams.
Minimum BA/BS in Business, Marketing, Finance, Science/Technology, or a related field.
Knowledge of pharmaceutical/biotechnology operations and an understanding of drug development.
Expertise in Microsoft applications including, but not limited to, Teams, Project, PowerPoint, Word, and Excel.
Highly organized and detail-oriented, with the ability to synthesize information and think strategically.
Self-motivated, flexible, proactive, and able to operate effectively in an ambiguous, fast-paced environment while meeting deadlines under pressure.
Demonstrated ability to prioritize and manage multiple projects simultaneously.
Proven ability to work effectively with individuals at all levels of the organization, including senior leadership.
Experience contributing to or leading cross-functional strategic change initiatives.
Excellent interpersonal, teamwork, and stakeholder management skills.
Strong written and verbal communication skills, including the ability to summarize complex information clearly and concisely.
Effective influencing and negotiation skills.
Ability to handle confidential information with discretion.

Nice To Haves

Advanced degree preferred but not required (MS, PhD, or MBA), particularly with experience supporting a science-based organization or function.

Responsibilities

Oversee strategic activities including objective and goal setting, quarterly reporting, resource and budget planning oversight, team communications, alignment of interdepartmental and cross-functional activities, and issue management.
Work collaboratively as part of the RA, GPS & DQ Strategy and Operations team to help drive the function's vision, mission, and organizational evolution.
Be accountable for collaborating with all RA, GPS & DQ functional lines and, as required, facilitate execution of strategic objectives.
Spearhead implementation of initiatives, including project tracking and ensuring appropriate cross-functional connections with key stakeholders.
Support stakeholder management across RA, GPS & DQ.
Monitor operational performance and quality delivery across the functional organization.
Drive the development and tracking of functional goals, including coordinating periodic functional reviews, collating quarterly status updates, and ensuring timely issue escalation and resolution.
Facilitate the development, maintenance, and review of management reports and dashboards that enable informed decision-making and strategic action.
Facilitate planning discussions, providing visibility and insights to support leadership decision-making.
Partner in the development of job descriptions, requisition management activities, headcount openings, and active postings.
Collaborate with HR to support employee onboarding, engagement, and talent review processes.
Support budget planning and spend tracking activities by coordinating with functional leadership and Finance, providing reporting and insights to inform decision-making.
Own key functional meetings, communications, engagement activities, and team events. This includes preparing agendas, meeting materials, tracking actions and deliverables, and driving follow-up activities.
Ensure appropriate communication cascades within and outside the organization in partnership with Corporate Communications and the RA, GPS & DQ Chief of Staff.
Represent the functional Senior Leadership Team at delegated meetings, events, and activities.
May directly supervise administrative support staff for select activities and projects.
Actively participate in operational optimization activities supporting the broader Regulatory Affairs, Global Patient Safety & Development Quality organization and the broader Global Development organization.
Participate in continuous improvement initiatives.
Foster a team environment that reflects the values of the Regeneron Way