Global Regulatory Affairs - Labeling Specialist (m/w/d)

TECCON Consulting GmbH; Österreich; Híbrido; EUR 68.000 - 83.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working hours

Remote work options

Career development opportunities

Descripción de la vacante

TECCON Consulting GmbH in Hamburg is seeking an experienced Regulatory Affairs professional to lead global labeling initiatives for development and marketed products. You will collaborate with regulatory, pharmacovigilance, medical affairs and commercial teams to drive labeling strategies.

The ideal candidate has 2–3 years in Global Labeling or Regulatory Affairs, a Master’s or PhD in a related field, and fluent English.

Formación

• 2–3 years of regulatory labeling or regulatory affairs experience in pharma.
• Strong understanding of labeling requirements across global markets.
• Experience in leading cross-functional projects in a matrix environment.

Responsabilidades

• Develop and implement labeling strategies for development and marketed products.
• Define submission strategies and assess labeling requirements across global markets.
• Evaluate safety-related labeling changes and provide regulatory input on CDS and risk communication.
• Prepare and review labeling documents and responses to Health Authority queries.
• Support regulatory interactions with Health Authorities.
• Lead cross-functional workstreams and ensure timely delivery of labeling packages.
• Contribute to process optimization of labeling processes and regulatory systems.

Conocimientos

Regulatory affairs

Labeling

Project management

Communication

Problem solving

English proficiency

Educación

Master’s/PhD in related field

Descripción del empleo

Are you an expert in your field and ready to apply your know-how to exciting projects?

As part of the Hamburg-based TECCON Group—with over 450 employees in IT, engineering, and business—we develop innovative solutions for renowned clients. Our mission is to recognize and nurture human potential by creating tailored connections between companies and talent. Contribute your expertise to our projects and help shape the future.

Your Key Responsibilities:

• Global Labeling: You develop and implement labeling and artwork strategies for development and marketed products.
• Regulatory Strategy: You define submission strategies and assess labeling requirements across global markets. Safety & Compliance: You evaluate safety-related labeling changes and provide regulatory input on CDS and risk communication.
• Regulatory Documentation: You prepare and review labeling documents and responses to Health Authority queries.
• Health Authorities: You support regulatory interactions and negotiations related to labeling updates.
• Cross-Functional Collaboration: You work closely with Regulatory Affairs, Pharmacovigilance, Medical Affairs and Commercial teams.
• Project Ownership: You independently lead workstreams, manage priorities and ensure timely delivery of labeling packages.
• Process Excellence: You contribute to the optimization of labeling processes, quality standards and regulatory systems.

Your Profile:

• Education: You hold a Master’s or PhD in Pharmacy, Chemistry, Biology, Life Sciences or a related field.
• Regulatory Experience: You have 2–3 years of experience in Global Labeling or Regulatory Affairs, or comparable pharmaceutical industry experience.
• Labeling Expertise: You have a good understanding of pharmaceutical labeling, regulatory requirements and drug safety.
• Project Skills: You can lead cross-functional workstreams in a matrix environment and manage multiple priorities independently.
• Communication: You have strong communication, negotiation and stakeholder management skills.
• Problem Solving: You work analytically, independently and with a strong quality and compliance mindset.
• Languages: You have excellent written and spoken English skills.
• Exciting challenges and responsible tasks with plenty of creative freedom and personal responsibility
• Long-term career prospects in a dynamic and dedicated team
• Flexible working hours and remote work options to support a healthy work-life balance
• Diverse development and training opportunities to help you reach your full potential
• Engaging team events that strengthen team spirit and add variety to your work life

The gross annual fulltime salary is at least EUR 75.000 but of course we offer overpayment in line with the market, depending on qualifications and professional experience.