Senior Manager, Global Labeling Product Leader

Get 360Pharma; Warszawa; On-site; PLN 253,000 - 381,000; Full time

Job summary

A global leader in healthcare innovation is seeking a Senior Manager, Global Labeling Product Leader for their team. This hybrid role can be based in Warsaw, Poland, or Beerse, Belgium. The ideal candidate will have a strong background in regulatory affairs with over 8 years of experience and will be responsible for managing regulatory activities concerning product labeling. Excellent communication and organizational skills are essential for this position.

Qualifications

• A minimum of 8 years of professional work experience is required.
• A minimum of 6 years of direct regulatory labeling content experience is required.
• Experience leading project teams in a matrix environment is required.

Responsibilities

• Develop methods for planning and coordinating regulatory affairs activities.
• Ensure compliance with regulatory agency regulations and interpretations.
• Drive a collaborative, customer-focused, and learning culture.

Skills

Regulatory Affairs

Medical Writing

Project Management

Analytical Reasoning

Strategic Thinking

Education

Bachelor’s degree in a scientific discipline

Tools

Document management systems

Job description

Apply now

About the vacancy

Quality
Compliance
Regulatory Affairs
Regulatory compliance
Medical Writing
Staff
Project Management

Sr Manager, Bachelor’s Degree (HBO, WO), Permanent, Full time, 2340 Beerse, Belgium

About Your Next Job

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is a hybrid role and can be located in Beerse, Belgium or Warsaw, Poland.

The Senior Manager, Global Labeling Product Leader is a leading expert individual contributor who is viewed as a valuable resource by peers and manages large projects or processes. This individual will develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations.

About Your Skills and Experience

Qualifications:

• A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
• A minimum of 8 years of professional work experience is required.
• A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.
• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
• An understanding of pharmaceutical drug development is required.
• Experience in discussing and communicating scientific concepts is required.
• Good understanding of worldwide regulatory guidelines and their application for guidance for labeling is required.
• Experience leading project teams in a matrix environment is required.
• Experience leading continuous improvement projects is required.
• Experience working with document management systems is required.
• Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.
• Must have exceptional verbal and written communication skills.
• Must have strong organizational, negotiation, and partnering skills.
• Must have the ability to work independently.
• The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.
• The ability to drive a collaborative, customer-focused, learning culture is preferred.

Preferred Skills:

Analytical Reasoning, Business Writing, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility

Where Molecules Meet Opportunities

Hybrid Work

You are eligible to work in EU

We only accept applicants who are eligible to work in the EU

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 https://www.jnj.com