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 Affairs
Job Category:
Professional
All Job Posting Locations:
Madrid, Spain
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 as Local Regulatory Expert to be in Madrid, Spain
Purpose: Join an innovative company like Johnson & Johnson as a vital part of the Regulatory Affairs Department. In this role, you will contribute to shaping the future of healthcare by ensuring that our products meet rigorous regulatory standards while collaborating closely with cross-functional teams. This opportunity allows you to be at the forefront of delivering safe and effective solutions to patients and healthcare professionals worldwide.
Key Responsibilities:
- Regulatory Strategy Support: Collaborate in the development of new and existing products, ensuring compliance with regulatory requirements for market introduction.
- Regulatory Intelligence: Provide insights on competitive and regulatory intelligence to anticipate and mitigate risks.
- Compliance Assurance: Ensure compliance with local, regional, and Janssen regulations, minimizing risks to patients and the company.
- Project Management: Oversee the creation and approval of product monographs and other related documents.
- External Relations: Build and maintain positive relationships with local health authorities and healthcare professionals.
- Cross-Departmental Collaboration: Engage and support various departments, including Market Access, Marketing, Medical Affairs, Pharmacovigilance, Quality, Corporate Communication, and Legal, to ensure alignment on regulatory strategies and compliance.
Minimum Qualifications:
- University degree in Pharmacy, Biology, Chemistry, or Life Sciences.
- 3 to 5 years of Regulatory Affairs experience with product management responsibilities.
- Knowledge of regulatory requirements and promotional material review experience.
Required Competencies:
- Analytical and conceptual skills.
- Strategic and results-oriented approach.
- Effective communication and presentation abilities.
- Understanding of Regulatory Legislation: Knowledge and interpretation of product regulatory legislation and guidelines.
- Compliance Awareness: Ability to understand broader compliance issues and their impact on launch timelines.
- Relationship Building Skills: Capacity to build relationships with cross-functional teams and collaborators.
- Social Awareness: Ability to influence and interact effectively within a diverse environment.
Other Requirements:
- Native in the relevant local language (Spanish) and fluent in English.
- Willingness to travel as necessary.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is:
€43.600,00 - €70.150,00
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.