Labeling Strategist (m/f/x) (Global Labeling Strategy Lead)

JR Germany; Bonn; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Global Regulatory Affairs Labeling Expert to provide strategic leadership on product labeling. This exciting role involves collaborating with global teams, managing complex projects, and ensuring compliance with regulatory standards. With options for onsite, hybrid, or remote work, this position offers flexibility and the chance to make a significant impact in the pharmaceutical industry. If you have a strong background in regulatory affairs and a passion for improving healthcare solutions, this opportunity is perfect for you.

Qualifikationen

• 7+ years in the pharmaceutical industry with 4+ years in regulatory affairs.
• Experience in EU/US labeling and CCDS is essential.

Aufgaben

• Lead cross-functional teams in labeling discussions with regulatory authorities.
• Manage preparation of regulatory documents like USPI and EU SmPC.

Kenntnisse

Regulatory Affairs

Labeling Compliance

Project Management

Interpersonal Skills

Ausbildung

Bachelor's Degree in a Scientific Discipline

Advanced Degree

Jobbeschreibung

Social network you want to login/join with:

col-narrow-left

Client:

Location:

bonn, Germany

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

2

Posted:

02.05.2025

Expiry Date:

16.06.2025

col-wide

Job Description:

Daiichi Sankyo, with over 120 years of experience and approximately 19,000 employees across more than 30 countries, is dedicated to discovering and delivering innovative healthcare solutions. Our European focus includes protecting against cardiovascular diseases and advancing oncology treatments, aiming to improve patients' lives.

Our headquarters are in Munich, Germany, with affiliates throughout Europe and Canada. We are seeking highly qualified candidates for the position of:

Global Regulatory Affairs Labeling Expert

This role involves providing strategic and operational leadership on product labeling, collaborating with global teams, managing complex projects, and ensuring compliance with regulatory standards. The position may be based anywhere in Europe (excluding Belgium and Greece), with options for onsite, hybrid, or remote work.

Key Responsibilities:

• Serve as the main contact for global labeling issues and lead cross-functional teams in labeling discussions with regulatory authorities.
• Manage the preparation and implementation of regulatory documents such as USPI, EU SmPC, and CCDS.
• Lead review processes and ensure governance for labeling documents across regions.
• Research and ensure compliance with health authority labeling regulations.
• Develop and improve standard operating procedures and best practices in labeling.
• Build strong cross-regional relationships and coordinate with external partners.

Minimum Qualifications:

• Bachelor's degree in a scientific discipline; advanced degrees preferred.
• At least 7 years of pharmaceutical industry experience, with 4+ years in regulatory affairs, including EU/US labeling.
• Experience with CCDS and EU labeling is essential; ex-EU labeling experience is a plus.
• Ability to travel up to 10% occasionally.
• Strong interpersonal skills and ability to work independently and in teams.