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

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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 searching for the best talent for a Manager, RA Submissions. This hybrid work position will be located in Leiden, The Netherlands or Warsaw, Poland

The Manager, RA Submissions is a highly independent position, responsible for the submission operational management and delivery of global regulatory submissions required at a compound level to support the development, registration, and compliance of products.  This position works under minimal direction and is responsible for organizing their own time efficiently to maximize contributions.

Key Responsibilities:

• Coordinate the preparation and maintenance of global regulatory submissions and filings in line with regulatory strategy.

• Create and manage dossier plans/submission packages, seeking input from regulatory therapeutic areas, functional area representatives, and key partners, while providing guidance to project team members.

• Contribute to decisions that have an impact on the quality and timeliness of Health Authority submissions.
• Make decisions on submission operational strategies for an optimal project management approach within process/timeline/resource constraints.
• Lead cross-functional submission team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.
• Leadership role for the monitoring and efficiency of the submission process, initiate changes within the scope of decision-making authority to optimize efficiencies and ensure quality.
• Cultivate effective relationships, maintaining open communication with key partners to ensure priority challenges, resource issues, and deviations from the plan are identified and resolved.
• Demonstrated ability to lead the development of strategic initiatives, departmental work practices, process enhancements/improvements, and associated training materials.
• May be responsible for performance and development of direct reports.

Experience and skills:

Education

• University/bachelor’s degree and 6 years of related professional experience.
• Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience.

Required:

• In-depth understanding of the drug development process across regional and functional areas.
• Effective interpersonal, teamwork, and communication skills.
• Ability to work or lead in a matrix environment and influence stakeholders, strong collaboration skills.
• Fluency in English; other languages may be required depending on assignment.
• Knowledge of Regulatory Information Systems, planning, and publishing tools.
• Knowledge and skills to build productive relationships across the organization and with external stakeholders.
• In-depth knowledge of project and submission management. 
• Demonstrated proactivity, problem solving, trouble shooting, and adaptability.
• Proficiency in submission related HA and Industry regulations and guidelines as relevant.

Preferred:

·         Minimum 6 years progressive business experience within Regulatory Affairs or interfacing business areas 

·         Minimum 1-3 years of experience within Global Regulatory Affairs with Masters/PharmD/ PhD degree

Other:

• May require up to 5% travel, domestic and international.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

United Kingdom - Requisition Number: R-021402

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.