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:

We are searching for the best talent for a Regulatory Affairs Specialist to be based in Ljubljana, Slovenia.

This position is part-time (50% working time) and a time-limited contract of one year. In this role, you will be working in a hybrid office/home model.

As the Experienced RA Professional LOC for Slovenia, you will play a pivotal role in managing regulatory activities for our portfolio of Johnson & Johnson Innovative Medicine products in the country. You will collaborate closely with cross-functional teams in country and abroad, ensuring compliance with local and European regulatory requirements.

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

If you are a passionate and dedicated individual seeking to make a difference in the field of Regulatory Affairs, we invite you to join us at Johnson & Johnson Innovative Medicine. Together, we can transform lives and shape the future of healthcare.

Key Responsibilities:

• Partners with local RA team with regards to regulatory activities for the Johnson & Johnson Innovative Medicine portfolio
• Collaborate with cross-functional regional/global and in country teams to ensure timely and quality regulatory submissions, including review and approval of regulatory documents and labeling and to align strategies and share standard methodologies
• Supervise and interpret local regulatory requirements and guidelines in Slovenia, providing mentorship and training to ensure compliance
• Support regulatory inspections and audits and facilitate timely resolution of any regulatory issues or deficiencies
• Ensure compliance with local regulatory requirements and company standards.

Education:

• University degree or equivalent experience in life sciences field or a related field.

Experience and Skills:

• Shown experience in Regulatory Affairs within the pharmaceutical/biotechnology industry (at least 4-5 years in industry field)
• Solid understanding of regulatory requirements and procedures in Slovenia and EU legislation.
• Excellent understanding of the drug development process, including clinical trials, pharmacovigilance, and post-market surveillance.
• Ability to effectively communicate regulatory information to diverse partners, both internally and externally.
• Profound English language skills
• High attention to details and analytical skills (e.g., systems, documentation, metrics)
• Ability to independently plan, organize, co-ordinate, proactively lead and complete tasks