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Manager, RA Submissions - Job Opportunity at Johnson & Johnson

Leiden, Netherlands
Full-time
Senior
Posted: June 10, 2025
Hybrid
EUR 85,000 - 110,000 annually based on senior-level regulatory affairs management position in Netherlands/European market, with potential for additional benefits and international assignment premiums

Benefits

Hybrid work arrangement providing flexibility to balance remote productivity with in-person collaboration, positioning candidates competitively in today's flexible work market
International career opportunities across multiple European locations including Netherlands, Poland, and UK, offering significant geographic mobility and cross-cultural experience
Access to cutting-edge pharmaceutical development projects in innovative medicine, providing exposure to next-generation therapeutic solutions
Leadership development opportunities through direct report management and cross-functional team coordination
Professional growth through involvement in global regulatory strategy and health authority interactions

Key Responsibilities

Drive strategic regulatory submission operations at compound level, directly impacting global drug development timelines and patient access to innovative therapies
Architect comprehensive dossier strategies and submission packages that align with multi-million dollar development programs and regulatory pathways
Lead critical decision-making processes affecting submission quality and timing for sophisticated health authority filings that determine market entry success
Execute operational excellence initiatives to optimize submission processes, directly contributing to organizational efficiency and competitive advantage
Build and maintain strategic partnerships across therapeutic areas and functional teams to ensure seamless project delivery and conflict resolution
Champion process innovation and departmental enhancement initiatives, establishing best practices that influence organizational regulatory capabilities
Provide leadership and development guidance to direct reports, building regulatory talent pipeline and organizational capability

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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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented regulatory complexity due to personalized medicine and advanced therapy medicinal products (ATMPs), creating high demand for experienced regulatory professionals who can navigate evolving submission requirements across multiple jurisdictions. Digital transformation in regulatory affairs is accelerating with electronic Common Technical Document (eCTD) evolution and AI-assisted submission preparation, requiring professionals who can adapt to new technologies while maintaining regulatory compliance standards. Post-Brexit regulatory landscape has created additional complexity for European submissions, increasing demand for professionals with multi-jurisdictional experience who can manage parallel regulatory pathways across EU, UK, and other global markets.

Role Significance

Typically manages 3-8 direct reports including regulatory associates and specialists, while coordinating with cross-functional teams of 15-25 professionals across therapeutic areas, clinical operations, and regulatory intelligence
Senior management position with significant operational responsibility, evidenced by compound-level accountability, direct report management, and authority to make strategic decisions affecting multi-million dollar development programs

Key Projects

Global Clinical Trial Application (CTA) submissions for Phase I-III studies across EU member states Integrated regulatory dossier preparation for Marketing Authorization Applications (MAAs) Regulatory strategy development for novel therapeutic modalities including biologics and advanced therapies Health authority interaction management including scientific advice procedures and regulatory meeting preparation

Success Factors

Deep technical expertise in ICH guidelines and regional regulatory requirements combined with strategic thinking ability to translate complex scientific data into compelling regulatory narratives Exceptional stakeholder management skills to influence cross-functional teams without direct authority while maintaining project timelines and quality standards Adaptability to rapidly changing regulatory landscape including new guidelines, digital submission requirements, and emerging therapeutic area-specific regulations Strong analytical and problem-solving capabilities to navigate complex regulatory scenarios and develop innovative solutions within established frameworks

Market Demand

High demand driven by increasing pharmaceutical R&D investment, regulatory complexity, and shortage of experienced regulatory professionals with compound-level submission management expertise

Important Skills

Critical Skills

Regulatory submission expertise is fundamental as it directly impacts the ability to secure health authority approvals and bring innovative medicines to patients, requiring deep understanding of complex technical requirements and evolving regulatory science Matrix leadership capabilities are essential given the cross-functional nature of pharmaceutical development, where success depends on influencing diverse stakeholders without direct reporting authority Project management proficiency is critical for managing complex submission timelines with multiple dependencies, regulatory deadlines, and resource constraints that directly impact commercial launch timing

Beneficial Skills

Additional European language proficiency would enhance effectiveness in multi-jurisdictional submissions and health authority interactions across diverse European markets Digital regulatory technology experience including AI-assisted document preparation and advanced eCTD systems would provide competitive advantage in evolving regulatory landscape Therapeutic area specialization in high-growth areas such as oncology, immunology, or cell and gene therapy would align with J&J's strategic priorities and pipeline focus

Unique Aspects

Opportunity to work within Next Generation Submissions (NGS) organization, indicating involvement with cutting-edge submission technologies and process innovation initiatives
Multi-country flexibility across three strategic European locations provides exceptional geographic mobility and cultural diversity experience
Compound-level accountability offers direct impact on drug development success and patient access to innovative therapies
Integration with Innovative Medicine division provides exposure to breakthrough therapeutic modalities and novel regulatory challenges

Career Growth

Progression to director-level positions typically occurs within 3-5 years with demonstrated success in compound management and regulatory strategy development

Potential Next Roles

Senior Director Regulatory Affairs Global Regulatory Lead Head of Regulatory Operations Director Clinical Development Strategy

Company Overview

Johnson & Johnson

Johnson & Johnson represents the world's largest and most diversified healthcare conglomerate, with pharmaceutical revenues exceeding $50 billion annually and a robust pipeline spanning oncology, immunology, neuroscience, and infectious diseases through its Innovative Medicine division.

Global market leader in pharmaceutical innovation with established regulatory affairs organization recognized for successful navigation of complex international submissions and maintenance of strong health authority relationships
This role supports J&J's significant European operations with strategic positioning in Netherlands (Leiden) serving as key regulatory hub for EMEA region, offering exposure to high-impact global development programs
Matrix organization structure emphasizing collaboration and cross-functional partnership, with strong emphasis on patient-centric decision making and scientific excellence in regulatory strategy development
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