Director, RA Submissions CTA

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at role is the global capability leader accountable for endtoend stewardship of Clinical Trial Application (CTA) submission delivery across the global portfolio with particular accountability for EU compliance-critical elements including inspection ready execution under European regulatory frameworks such as the EU Clinical Trial Regulation (EU CTR). This role sets strategic direction for how CTAs are planned governed and delivered at scale ensuring consistent highquality and compliant submissions that support clinical development objectives across regions and therapeutic areas.

This role shapes the CTA submission operating model defines global standards and expectations and drives continuous improvement aligned with regulatory requirements inspection readiness and future development needs.

The role provides leadership to a team of professionals with a focus on building deep expertise strong succession and a balanced talent pipeline to enable the capability. The role serves as a senior RODI leader in Poland providing visible leadership integration across functions and escalation support for Polandbased RODI team members. This role cultivates a culture of empowerment collaboration and accountability while driving process development and innovation. As a member of the NGS Leadership Team this role contributes to organizational and operational strategies and partners to optimize business value. This role actively engages in initiatives to address systemic risks develop future submission models and influence improvement of submission delivery with a particular focus on EU regulatory evolution inspection findings and external authority expectations.

• Own endtoend CTA submission stewardship defining strategy operating models standards and controls to ensure consistent highquality delivery across global programs with primary accountability for EU compliancecritical elements.
• Provide people and capability leadership ensuring the right talent skills capacity and succession are in place across globally distributed teams and matrixed execution organizations.
• Maintain global oversight of CTA submission planning and delivery while serving as the primary accountable regulatory leader for EU CTR compliance execution requirements and CTA inspection readiness.
• Supervise capacity planning and resource deployment to ensure CTA submissions demand can be met in line with regulatory strategy regional requirements and business priorities.
• Drive the development implementation monitoring and ongoing evaluation of CTA submission planning and delivery processes standards and practices identifying systemic risks inefficiencies and quality gaps and implementing scalable solutions with emphasis on EU CTR compliance execution predictability and inspection readiness.
• Establish and maintain robust governance and oversight mechanisms to proactively address complex highrisk or businesscritical CTA challenges.
• Partner with Global Development study teams and other trialexecuting functions to agree shared expectations and accountability for CTA readiness and submission execution.
• Assess build and adapt CTA submissions capabilities across process technology and resourcing developing futurefocused submission models that incorporate regulatory evolution inspection feedback data dependencies and emerging ways of working to improve predictability and resilience.
• Act as a subject matter authority for CTA submissions within GRA influencing crossfunctional strategy decisionmaking prioritization and internal and external standards development.
• Contribute to the strategic direction and operational framework of the NGS organization including capability integration and enterprise initiatives impacting submission delivery.
• Serves as a senior RODI leader in Poland providing visible leadership integration across functions and escalation support for Polandbased RODI team members.

Education:

• Bachelors degree in scientific discipline

Required:

• 8 years overall work experience
• 6 years in pharmaceutical or healthcare industry
• Demonstrated knowledge of the product development process and regulatory affairs including submission requirements and industry standards
• Demonstrated experience working within or closely supporting European regulatory frameworks including interaction with EU Competent Authorities and Ethics Committees or equivalent regionally complex regulatory environments
• Experience supporting compliancedriven submission execution and inspection readiness in highly regulated jurisdictions

• People management experience including leadership of globally distributed teams and matrixed organizations
• Understanding of project management and submission management capabilities
• Excellent communication skills both written and verbal at all levels of the organization.
• Strong analytical and problem-solving skills.
• Ability to work independently and in a team environment.
• Ability to lead and develop a team with varied strengths.
• Ability to handle constructive conflict and manage issues.

• Masters degree or equivalent
• Resource management experience (FTE and contractor)
• Experience leading or overseeing regulatory or submission operations within an EU or regionally complex regulatory environment

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.