Regulatory Program Manager

Regulatory Program Manager at Net2Source (N2S) Regulatory Program Manager at Net2Source (N2S) in Princeton, New Jersey Posted in about 2 hours ago.

Type:

full-time

Job Description:

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap

• Right Talent
• Right Time
• Right Place
• Right Price and acting as a Career Coach to our consultants.

Company:

One of Our Clients Job Title:

Associate Director•

Regulatory Program Locations:

50% onsite at Princeton Pike, NJ 08648

Duration:

09+ months (Extendable)

Work Schedule:

Mon-Fri 8am-5pm

Pay Rate:

$115.00

• 123.

29/hr on W2

Top Requirements:

• At least 10 years of drug development experience spanning early development (Ph1) through commercialization; regulatory experience is preferred; advanced degree (MBA, MS, PhD) preferred, PMP preferred; Overview This role supports late-stage drug development programs as a Program Manager working closely with a Program Management Lead and Global Program Team (GPT).

The position is highly collaborative and execution-focused, with an emphasis on supporting a major regulatory submission. The hire will not initially lead independently, but will function as a key partner to the Lead PM, taking on delegated responsibilities and helping drive cross-functional coordination, timelines, and deliverables. Strong hands-on experience in late-stage/registrational development is critical. The environment requires strong communication, attention to detail, and interpersonal effectiveness, as well as the ability to integrate into an established team and quickly contribute. Key Responsibilities Program Execution & Planning Maintain and manage integrated project plans (e.g., ePlan, Microsoft Project, Planisware) Develop and track detailed timelines, ensuring visibility into the critical path Support execution of the Integrated Development Plan (IDP) aligned with Target Product Profile (TPP) Assist with scenario planning, forecasting, and resource planning Cross-Functional Coordination Partner closely with: Global Program Lead (GPL) Program Management Lead Cross-functional sub-teams Act as a central coordinator to ensure alignment across functions Participate in GPT and sub-team activities to ensure execution against strategy Submission & Late-Stage Support Contribute to one major regulatory submission Support late-stage development activities, including preparation for governance and submission milestones Help manage risks, dependencies, and deliverables tied to submission readiness Risk, Budget & Governance Support Assist with risk management planning and mitigation Track budget and resource health, escalating concerns when needed Support governance preparation (timelines, scenarios, resourcing) Team & Operational Support Execute delegated tasks from Lead PM Demonstrate strong partnership and collaboration mindset Contribute to a high-performing, detail-oriented team environment Engage with PM tools, processes, and continuous improvement efforts Required Experience & Qualifications Core Experience ~8+ years in drug development program/project management Strong experience in late-stage / registrational programs (highly preferred) Hands-on involvement in global regulatory submissions (e.g., NDA/BLA/MAA) Broad understanding across clinical development (not just CMC or ClinOps-only) ?? Candidates with only CMC-focused OR only Clinical Operations backgrounds will not be considered Functional Expertise Experience working within Global Program Teams (GPTs) Proven ability to support complex, cross-functional programs Familiarity with end-to-end development lifecycle Technical Skills Proficiency in: Microsoft Project (required) Planisware (strongly preferred) Microsoft Office Suite Experience with project planning tools and data systems (ePlan or similar) Education & Certifications Bachelor's degree required (advanced degree preferred but not required) PMP certification preferred, not mandatory Key Competencies Strong communication skills (written & verbal) Highly detail-oriented and organized Strong interpersonal and collaboration skills Ability to manage competing priorities in a fast-paced environment Strong problem-solving and business acumen Preferred Background Experience in pulmonology and/or immunology Exposure to late-stage submission environments Experience working closely with a Lead PM on large programs Position Summary As an Associate Director, Program Manager, this team member is assigned at the asset and/or indication level to deliver integrated cross-functional planning, oversee execution and administrate the PM sub-team(s). They will also operate as a strategic partner to the Global Program Lead (GPL), to shape and deliver the Target Product Profile (TPP) and Integrated Development Strategy (IDP) for the assigned asset(s) and associated product indications. Responsible for the rigorous execution of the IDP individually or in partnership with assigned Program Management team members. Reports to a Drug Development, Program Management Portfolio Lead. Duties/Responsibilities

• Program Management SME delivering as a key partner to the GPL. Serves as a strategic thought partner to the GPL / GPT and core to establish a high performing team environment.
• Responsible for the execution of IDP per asset indication, this includes strong partnership with each sub-team and their leadership to ensure alignment to the TPP/IDP and clear understanding of what they are accountable to deliver.
• Facilitates team goal setting and tracking to ensure adherence to plan and strategy and in preparation for end of year team evaluation process.
• Leads matrixed PM team members (if assigned) to create and maintain integrated cross-functional timelines for each asset indication within approved systems. Timelines should include scenario plans that actively manage risk, evaluate alternative development strategies as well as acceleration opportunities (or cost savings).
• Leads risk management activities at the GPT and ensures risk management activities at the sub-teams and below are performed with timely escalation for high probability x high impact risks. Responsible for delivering the risk management plan, including risk management strategies.
• Responsible to monitor high level direct budget and resource health for assigned asset(s) and indications. Maintains visibility and advocates for the resources required to deliver the IDP per governance approval.
• Delivers as a PM SME in discussions with leadership or at governance stage gates.
• Supports GPT annual objective processes and budget planning including annual and long-term portfolio processes.
• May serve as a matrix manager for Program Management resources assigned to the asset.
• Supports DD PM Portfolio Leads to deliver asset or portfolio content as required.
• Foster cross-functional thinking to drive and shape program strategy and drive optimal decisions for the broader portfolio. Qualifications
• Advanced degree (MS/MBA or Ph.D. desirable) in Life Sciences, Chemical Sciences, Physical Sciences, or other relevant discipline. PMP certification is desirable.
• At least 8 years of direct experience in drug development program / project management. Ideal candidates will have experience in various therapy areas.
• Demonstrated varied experience in research and drug development, including global regulatory submissions (IND/CTA through

NDA/BLA/MAA/JNDA/ NDA

China) and lifecycle management.

• Proven success as a PM delivering programs teams with high level of enterprise visibility. Long-standing experience which demonstrates strong matrix leadership abilities.
• Excellent written and verbal skills, (including full professional English proficiency).
• Must be well-organized and have strong attention to detail with an ability to deal with competing priorities; high level of problem-solving capability and business acumen, ability to balance competing priorities and quickly and objectively drive the team towards a path which maximizes value, while maintaining the end-to-end cross-functional view.
• Ability to present, influence, and gain alignment at senior governance and executive leadership levels.
• Demonstrated ability to manage interdependencies within therapeutic areas, disease areas, functions, and geographies.
• Fully competent in core PM methodologies and tools. Most specifically planning and control, risk management, stakeholder management and soft skills.
• Ability to resolve critical technical/business problems and shape long-term development strategy for programs of enterprise significance.