Senior Manager, RA Submissions

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

People Leader

All Job Posting Locations:

Leiden, Netherlands, Mechelen, Antwerp, Belgium, Warsaw, Masovian, Poland

Job Description:

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 https://www.jnj.com/innovative-medicine

We are seeking Senior Manager, RA Submissions to be located in Belgium, Netherlands or Poland.

Job requirements

• 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.

• Bachelor’s 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.

• Ability to work or lead in a matrix environment.

 

Key Responsibilities

• Lead and oversee a CTA team in planning, preparing, and maintaining regulatory submissions and filings, ensuring accuracy and compliance throughout the process. Provide guidance and support for direct reports to facilitate smooth submission workflows.

• 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.

• Maintain and promote up-to-date expertise on global and regional regulations, ensuring all submissions meet current guidelines, standards, and best practices.

• 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.

• Lead the development and alignment of submission operational strategies with overarching regulatory strategies, ensuring coherence and efficiency.

• Drive continuous improvement by leading the development and enhancement of departmental work practices, processes, and workflows.

• 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.

• Foster strong collaborations with key partners to proactively identify and resolve conflicts related to priorities, resource allocation, or deviations from plans, removing obstacles to ensure project success. Collaborate across GRA functions and relevant groups as needed for assigned projects