Johnson & Johnson Careers

Head of Global Regulatory Affairs for Vaccines

Leiden, South Holland
Regulatory Affairs


Job Description

Requisition ID: 1805661661W

Janssen Biologics, one of the Johnson & Johnson pharmaceutical companies, develop medicines for patients, doctors and other care providers. The Janssen group holds a leading position in a number of major disease areas, including diseases of the central nervous system, immune diseases, cancer, infectious diseases such as AIDS and hepatitis, and cardiovascular, metabolic disorders. Since 2011 the company also operates in the prevention area via a range of vaccines.

We have an opportunity for a senior executive to join the organization and lead the Vaccines Therapeutic Area Regulatory organization globally, drive the regulatory strategy for this therapeutic area, and deliver regulatory submissions and approvals.

Responsibilities:

• Participates actively as a member of the senior leadership teams of both the Global Regulatory Affairs (GRA) organization and Vaccines Therapeutic Area.

• Maintains external relationships at regulatory agencies and with the regulatory communities across each country in NA, LATAM, ASPAC and EMEA.

• Function as the expert and inspirational leader of the GRA Vaccines organizations supporting the R&D, Commercial and Supply Chain organizations of the Pharmaceuticals Group.

• Effectively lead the substantive, operational and administrative aspects of the Vaccines GRA organization to maximize business opportunities including financial management, leadership and organization development, talent management, external outreach and partner/stakeholder management.

• Oversee the development of effective and progressive global regulatory strategies for all products in the Vaccines Therapeutic Area from early development through the transition to mature products. Ensure thorough vetting, influencing and challenging of the regulatory strategies through a collaborative process with Therapeutic Area leadership to ensure alignment with the goals and objectives of the Pharmaceutical organization. Ensure that

regulatory strategies also take into account non-regulatory market access issues (e.g., health technology assessments, payor demands).

• Ensure, facilitate and/or lead the development or enhancement of constructive relationships and associations with key Health Authorities and thought leaders in appropriate business critical countries

• As a member of the Global Regulatory Affairs Senior Leadership Team, participate in setting  strategic and operational direction, sharing learnings and best practices, and ensuring achievement against personal and department goals.


Qualifications

Qualification:

• A minimum of 12 years in a regulatory affairs, drug development or R&D leadership role with relevant experience in the field of Vaccines.

• Substantial pharmaceutical industry or Health Authority experience globally and supported by business and technical acumen required.

• Significant experience in the development and execution of regulatory strategies, the drug development process, regulatory compliance, regulatory support for product lifecycle management and establishing productive working relationships with Health Authorities’ decision makers.

• Proven experience in leading and managing a large, diverse group of people in a dispersed, matrixed environment.

• Proven experience in risk management and collaboration in an international environment.

• Preferred PhD or MD degree, scientific area of study

At Janssen, every colleague makes a vital difference. Our people take pride in improving people’s health around the world. Each day, they make life better by going for high quality and continuous innovation. While doing so, they get the chance to grow their competences and take initiatives.

All of this in an international, value-driven group that cares for the wellbeing of its people.

A group that contributes to the quality of life as a global partner in healthcare.

Janssen is at the forefront of a new era in total healthcare solutions.

 


Primary Location
Netherlands-South Holland-Leiden
Organization
Janssen Biologics (7266)
Job Function
Regulatory Affairs
Requisition ID
1805661661W