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 GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Warsaw, Masovian, PolandJob Description:
About Innovative Medicine
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 Senior Analyst, RA Submissions for Registration Submission Management. This hybrid work position will be located in Warsaw, Poland.
The Senior Analyst, RA Submissions is responsible for the submission operational management and delivery of global regulatory submissions required to support the development, registration, and compliance of products. This position works with minimal supervision and is responsible for organizing their own time in an optimal fashion.
Key Responsibilities:
- Coordinates the preparation and maintenance of global regulatory submissions and filings in line with regulatory strategy.
- Creates and manages dossier plans/submission packages, seeking input from regulatory therapeutic areas, functional area representatives, and key stakeholders, while providing guidance to project team members.
- Contributes to decisions that have an impact on the quality and timeliness of Health Authority submissions.
- Makes decisions on submission operational strategies for the best project management approach within process/timeline/resource constraints.
- Leads cross-functional submission team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.
- Cultivates effective relationships, maintaining open communication with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved.
- Applies appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
- Monitors the effectiveness of the dossier process to identify improvement opportunities.
- Contributes to (and may lead) the development of strategic initiatives, departmental work practices, process enhancements/improvements, and associated training materials.
Education:
- University/bachelor’s degree or equivalent experience and 6 years of relevant/related professional experience.
- Masters/PharmD/PhD in combination with 1-3 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 problem solving, trouble shooting, and adaptability.
- Proficiency in submission related HA and Industry regulations and guidelines as relevant.
Other:
- May require up to 5% travel, domestic and international.