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Manager, RA Submissions - Job Opportunity at Johnson & Johnson

Leiden, Netherlands
Full-time
Senior
Posted: June 17, 2025
Hybrid
EUR 85,000 - EUR 120,000 annually, considering the senior management level, multiple European location options, and Johnson & Johnson's position as a premium pharmaceutical employer. The role's strategic importance in drug development and requirement for extensive regulatory expertise typically commands above-market compensation packages.

Benefits

Hybrid work arrangement providing flexibility to balance professional responsibilities with personal commitments while maintaining collaborative team engagement
International career opportunities across multiple European locations including Netherlands, United Kingdom, and Poland offering diverse cultural and professional experiences
Professional development through leadership of cross-functional teams and direct report management responsibilities
Access to cutting-edge regulatory technology systems and industry-leading submission platforms
Comprehensive training and development programs for regulatory affairs advancement

Key Responsibilities

Lead end-to-end regulatory submission strategy and execution for global pharmaceutical compounds, directly impacting drug development timelines and patient access to innovative treatments
Architect and manage complex dossier packages and submission strategies that determine regulatory approval success across multiple health authorities
Drive critical decision-making processes that influence submission quality, timeline optimization, and resource allocation for multi-million dollar drug development programs
Lead cross-functional submission teams and coordinate regulatory filing activities that are essential for bringing life-saving medications to market
Spearhead process improvement initiatives and operational excellence programs that enhance submission efficiency and regulatory compliance across the organization
Cultivate strategic partnerships with internal stakeholders and external regulatory bodies to resolve complex submission challenges and ensure project success
Develop and implement departmental best practices, training programs, and knowledge management systems that elevate team performance and regulatory expertise
Manage and mentor direct reports while fostering professional development in a high-stakes regulatory environment

Requirements

Education

University/bachelor's degree or Masters/PharmD/PhD

Experience

6 years of related professional experience with bachelor's degree, or 4 years with advanced degree

Required Skills

In-depth understanding of drug development process Ability to demonstrate in-depth knowledge of regulatory submissions, filings, and processes Ability to work and lead in a matrix environment Proven ability to build positive relationships and influence collaborators across an organization Proficiency in relevant submission-related Health Authority and Industry regulations and guidelines Proficient use of Regulatory Information Systems Fluency in English; other languages may be required depending on assignment Validated project or submission management capabilities Previous experience leading Submission Team meetings to coordinate the preparation and maintenance of submissions and filings
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Industry Trends

The pharmaceutical industry is experiencing unprecedented regulatory complexity as health authorities worldwide implement new digital submission requirements and real-world evidence standards, creating high demand for experienced regulatory professionals who can navigate evolving compliance landscapes. Companies are investing heavily in next-generation submission technologies and data management systems to streamline regulatory processes and reduce time-to-market for critical therapies. Global harmonization initiatives across regulatory agencies are driving the need for professionals with multi-regional expertise, particularly in European markets where Brexit has created additional submission pathway complexities. The industry is seeing increased focus on patient-centric drug development and accelerated approval pathways, requiring regulatory managers who can adapt traditional submission strategies to new paradigms. Digital transformation in regulatory affairs is accelerating, with artificial intelligence and automation technologies being integrated into submission management processes. This technological evolution is creating opportunities for regulatory professionals who can bridge traditional pharmaceutical knowledge with modern digital submission capabilities and data analytics expertise.

Role Significance

Typically manages 3-8 direct reports including regulatory specialists, submission coordinators, and project managers, while leading cross-functional teams of 15-25 professionals across multiple therapeutic areas and geographic regions during major submission campaigns.
Senior management position with significant strategic influence over drug development timelines and regulatory approval success. The role carries substantial responsibility for multi-million dollar submission programs and requires advanced decision-making authority in complex regulatory scenarios. This position typically reports to senior regulatory leadership and interfaces directly with C-level executives on critical submission matters.

Key Projects

Global New Drug Application submissions for innovative therapeutic compounds with market values exceeding $1 billion annually Multi-regional Clinical Trial Application coordination across FDA, EMA, and other international health authorities for Phase II and Phase III development programs Regulatory strategy development for orphan drug designations and breakthrough therapy submissions requiring expedited review pathways Post-market regulatory maintenance including annual reports, safety updates, and manufacturing change notifications across global markets

Success Factors

Exceptional project management capabilities combined with deep regulatory science knowledge are essential for managing complex, multi-year submission timelines with numerous interdependent workstreams and regulatory milestones. Success requires the ability to anticipate regulatory challenges and develop contingency strategies that prevent costly delays in drug development programs. Advanced stakeholder management and cross-functional leadership skills are critical for influencing diverse teams including clinical development, manufacturing, quality assurance, and commercial organizations. The role demands the ability to build consensus among competing priorities while maintaining regulatory compliance and submission quality standards. Strategic thinking and business acumen are vital for understanding how regulatory decisions impact overall drug development strategy, commercial viability, and patient access. Successful managers must balance regulatory risk management with business objectives while ensuring scientific integrity throughout the submission process. Cultural competency and global regulatory knowledge are increasingly important as pharmaceutical companies operate across multiple jurisdictions with varying regulatory requirements. Success requires understanding regional differences in regulatory expectations while maintaining consistent global submission standards.

Market Demand

Very high demand driven by critical shortage of experienced regulatory submission managers worldwide, particularly those with Clinical Trial Application expertise and multi-regional knowledge. The specialized nature of pharmaceutical regulatory work and increasing complexity of global submissions create a highly competitive talent market.

Important Skills

Critical Skills

Deep regulatory submission expertise is absolutely essential as this role directly impacts drug approval timelines and patient access to life-saving treatments. Professionals must understand complex regulatory pathways, health authority expectations, and submission technical requirements across multiple jurisdictions. This knowledge directly translates to career advancement opportunities and market value in the pharmaceutical industry. Matrix leadership and cross-functional collaboration skills are vital because regulatory managers must influence and coordinate diverse teams without direct authority over all team members. Success requires building consensus among competing priorities while maintaining regulatory compliance standards. These leadership capabilities are fundamental for advancement to senior regulatory roles. Project management excellence is critical given the complexity and high stakes of pharmaceutical submissions, where delays can cost millions of dollars and delay patient access to needed therapies. Strong project management skills enable professionals to handle multiple concurrent submissions while maintaining quality standards and regulatory compliance. Strategic thinking and business acumen are essential for understanding how regulatory decisions impact overall drug development strategy and commercial success. Professionals who can balance regulatory requirements with business objectives while ensuring patient safety are highly valued for senior leadership positions.

Beneficial Skills

Advanced knowledge of digital submission technologies and regulatory information systems provides competitive advantages as the industry continues its digital transformation. Professionals with expertise in electronic submissions, data management, and emerging technologies are positioned for leadership roles in next-generation regulatory organizations. Multi-regional regulatory expertise, particularly in European markets post-Brexit, offers significant career advantages as pharmaceutical companies seek professionals who can navigate complex regulatory landscapes across multiple jurisdictions. This knowledge is increasingly valuable for global regulatory leadership positions. Therapeutic area specialization in high-growth areas such as oncology, rare diseases, or cell and gene therapy provides career acceleration opportunities as these areas represent the future of pharmaceutical innovation and require specialized regulatory expertise.

Unique Aspects

Opportunity to work within Johnson & Johnson's Next Generation Submissions organization, representing the company's cutting-edge approach to regulatory technology and digital submission strategies that are setting industry standards for submission efficiency and quality
Multi-country location flexibility across three European markets provides unprecedented career mobility and cultural diversity, allowing professionals to gain regulatory expertise across different health authority systems and regulatory frameworks
Exposure to Johnson & Johnson's diverse therapeutic portfolio spanning oncology, immunology, and rare diseases offers broad regulatory experience that is highly valued in the pharmaceutical industry and provides exceptional career development opportunities
Access to industry-leading regulatory information systems and submission technologies that represent significant competitive advantages and provide valuable technical skills for career advancement

Career Growth

Typical progression to senior director level occurs within 3-5 years with strong performance, while advancement to VP level generally requires 5-8 years of continued excellence and expanded scope. Transition to C-level regulatory positions typically happens within 8-12 years for high-performing managers.

Potential Next Roles

Senior Director or Associate Vice President of Regulatory Affairs with expanded therapeutic area responsibility and P&L accountability Global Regulatory Lead positions overseeing worldwide submission strategies for major pharmaceutical portfolios Regulatory Affairs Vice President roles with enterprise-wide regulatory policy and strategy responsibilities Chief Regulatory Officer positions at mid-size pharmaceutical or biotechnology companies Regulatory consulting leadership roles with premier pharmaceutical consulting organizations

Company Overview

Johnson & Johnson

Johnson & Johnson represents one of the world's largest and most diversified healthcare corporations, operating across pharmaceutical, medical device, and consumer health sectors with over $94 billion in annual revenue. The company's Innovative Medicine division focuses on breakthrough treatments for serious diseases including oncology, immunology, neuroscience, and rare diseases, maintaining one of the industry's most robust R&D pipelines with over 200 compounds in various development stages.

Johnson & Johnson consistently ranks among the top 3 global pharmaceutical companies by revenue and maintains industry-leading positions in multiple therapeutic areas. The company's regulatory affairs organization is considered a gold standard in the industry, known for sophisticated submission strategies and strong relationships with global health authorities.
The European operations represent a critical component of J&J's global strategy, with major regulatory hubs in Leiden and other European cities supporting worldwide submission activities. The company's multi-location approach offers unique career development opportunities and exposure to diverse regulatory environments across multiple jurisdictions.
Johnson & Johnson maintains a collaborative, science-driven culture that emphasizes patient focus and ethical decision-making through its Credo principles. The company is known for investing heavily in employee development, offering extensive training programs, and providing opportunities for international assignments and cross-functional career growth.
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