Senior Regulatory Project Manager

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently looking for Senior Regulatory Project Manager.

Responsibilities:

• The primary responsibility is to support the regulatory activities related to vaccines in all global markets
• Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidances related to vaccines
• Additional responsibilities include:
• contribute to the preparation and editing of clinical trial and marketing applications;
• correspondence and direct interaction with Health Authorities; development of product-specific regulatory strategy documents;
• technical review and approval of master protocols, reports and other source documents;
• other related duties as assigned.

Experience and Key Competencies:

• Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred.
• Strong knowledge of EU and FDA regulations is required, experience with other markets is added value.
• Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
• Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
• Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential.
• The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader.

What we’re about:

Johnson & Johnson are an equal opportunity employer and value diversity. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.