Local Regulatory Expert

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.
5 to 8 years of Regulatory Affairs experience with product management responsibilities.
Strong 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: