Senior Healthcare Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Leiden Netherlands Mechelen Antwerp Belgium Warsaw Masovian Poland

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Learn more at are seeking Senior Manager RA Submissions to be located in Belgium Netherlands or Poland.

Strong leadership capabilities with proven experience in managing direct reports mentoring junior staff and fostering a collaborative work environment.
Proven understanding regulatory requirements related to Clinical Trial Applications including ICH-GCP EMA and other relevant guidelines.
Demonstrated experience leading and managing the preparation review and submission of CTAs to regulatory bodies.
Exceptional analytical skills to identify potential issues analyze complex data and develop effective solutions in a fast-paced regulatory environment.
Effective verbal and written communication skills with the ability to liaise confidently with internal teams and external partners.
Bachelors Degree or higher in Life Sciences Pharmacy Regulatory Affairs or a related field.
Strong organizational skills with the ability to manage multiple submissions and regulatory deadlines simultaneously.
Lead and oversee a CTA team in planning preparing and maintaining regulatory submissions and filings ensuring accuracy and compliance throughout the process. Manage all HR-related processes for the team including performance management development and fostering a positive work environment. Ensure team members are aligned with organizational goals and standards.
Drive the coaching and professional development of team members and colleagues promoting continuous improvement skill enhancement and a high-performance culture.
Provide leadership and oversight to the CTA team ensuring the application of appropriate regulatory submission standards processes and policies to ensure compliance with regulatory agencies.
Analyze team workload prioritize assignments and oversee the tracking of submission activities using relevant systems and tools to ensure timely delivery.
Actively participate in CTA leadership team meetings contributing strategic insights and supporting decision-making processes.
Ensure open timely and effective communication channels with all stakeholders and team members to facilitate smooth project execution and meet deadlines.
Bachelors degree and 8-10 years of overall experience required

• Masters/Pharm D/PhD with 6 years experience preferred
• People or team management experience required
• Prior senior leadership experience preferred
• Can work a hybrid schedule that includes work from home flexibility as well as a regular in-office requirement at one of the locations listed in the next section

Belgium Netherlands and Poland - Requisition #: Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

Compliance Management Cross-Functional Collaboration Design Thinking Developing Others Inclusive Leadership Leadership Operational Excellence Package and Labeling Regulations Process Improvements Product Packaging Design Regulatory Affairs Management Regulatory Compliance Risk Assessments Standard Operating Procedure (SOP) Strategic Thinking Sustainability Sustainable Packaging Team Management Transparency Reporting
Senior Manager