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Company

Johnson & Johnson · 5 hours ago

Regulatory Program Manager, Oncology

Spring House, PA

Full-time

Remote

Mid, Senior Level

$115K/yr - $198K/yr

5+ years exp

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Health CareMedical Device

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Empower teams to deliver the highest possible impact for our programs, business, and patients around the world.

Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. (e.g., MSP project plan, risk and opportunity playbooks, scenario evaluation and business case development).

Lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of worldwide submissions, driving processes to optimize global filing and launch sequencing, pre and post-submission activities, preparation for health authority meetings and additional major regulatory milestones.

Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making, challenging status quo and fostering impactful innovation.

Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required.

Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team including co-development partners and/or other external partners, as required. Liaise with Compound Development Team (CDT) and Senior Leadership Team (SLT) partners to prepare discussions and drive meeting outcomes.

Lead the operational execution of select marketing applications including, clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed submission plans, ensuring team roles, responsibilities and accountabilities, and positioning teams to proactively mitigate risks and enhance opportunities.

Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams.

Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery.

Build RPM value proposition through continuous refinement of delivery, prioritizing and focusing on areas of highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts.

Serve as a mentor and coach to other RPMs and team members.

As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.

Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory strategy developmentGlobal Regulatory AffairsProject managementCross functional managementBusiness process analysisGlobal regulationsProject management certificationRegulatory certification (RAC)Microsoft ProjectInfluencing decision-makingStrategic thinking

Required

A minimum of a Bachelor’s degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline.

A minimum of 5 years of industry/business experience is required.

A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area is required.

Experience in strategic planning and development of regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g., NDA, MAA, and lifecycle documents) is required.

Demonstrated understanding of Global Regulatory Affairs processes is required.

Project management experience leading global regulatory teams in a matrix setting is required.

Demonstrated experience conducting business process, scenario, and critical path analysis is required.

Knowledge of global regulations, guidelines and regulatory requirements is required.

Proficiency and demonstrated application of project management standards, planning and visualization tools is required.

Must have excellent verbal and written communication skills.

Must have strong innovative and strategic thinking skills.

The ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required.

The ability to resolve controversy and influence teams without formal authority is required.

The ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required.

This position will require up to 10% domestic and international travel.

Preferred

Experience leading submission teams and working with external partners is preferred.

Project management certification preferred.

Regulatory certification (RAC) preferred.

Proficiency with Microsoft Project is highly preferred.

Benefits

Medical

Dental

Vision

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Consolidated retirement plan (pension)

Savings plan (401(k))

Vacation - up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

Holiday pay, including Floating Holidays - up to 13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Company

Johnson & Johnson

Glassdoor

4.2

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.

Founded in 1886

New Brunswick, New Jersey, USA

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (43)

2022 (55)

2021 (40)

2020 (30)