Regulatory Affairs Specialist, 50%, 1-year contract

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Zagreb, Grad Zagreb, Croatia

Job 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 Regulatory Affairs Specialist to be based in Zagreb, Croatia. This is a hybrid, part-time position with a contract duration of one year.

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 best practices

• Monitor and interpret local regulatory requirements and guidelines in Croatia, providing guidance 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 in life sciences field or a related field.

Experience And Skills

• Proven experience in Regulatory Affairs within the pharmaceutical/biotechnology industry (at least 2-4 years in industry field)

• Solid understanding of regulatory requirements and procedures in Croatia 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 execute tasks

 

 

Required Skills:

 

 

Preferred Skills:

  

 

The anticipated base pay range for this position is:

€32,100.00 - €51,175.00

 

 

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

 

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.