Birgit Dieing

20+ years in the pharmaceutical industry across CDMO, licensing, regulatory affairs, and quality environments. Extensive experience in international contract negotiations and evaluation of development and manufacturing partnerships. Leadership background with budget responsibility and cross-functional collaboration across commercial, technical, and regulatory teams.

Specialist Quality Compliance - R-Pharm Germany GmbH - Illertissen, Germany

(2025-02)

Ensuring regulatory compliance within GMP-regulated manufacturing operations

• Performing product quality reviews and deviation assessments
• Reviewing and approving quality-critical documentation aligned with regulatory dossiers
• Acting as a key interface between Quality, Manufacturing, Analytics, and Regulatory Affairs
• Supporting internal and external audits

Manager Business Development – Proposals & Contracts - R-Pharm Germany GmbH - Illertissen, Germany

(2021-10 - 2025-01)

Prepared and coordinated development and manufacturing proposals in a CDMO environment

• Evaluated technical feasibility, regulatory requirements, and project risks
• Supported international customer communication and contract negotiations
• Contributed to structured evaluation of new business opportunities

Freelance Trainer - Helmholtz Association of German Research Centres e. V., Bizerba SE & Co. KG and IMAKA Institute for Management GmbH - Germany

(2011 - 2017)

Delivered leadership and resilience programs focusing on self-leadership, stress management, and team effectiveness

• Developed and facilitated "Healthy Leadership" programs across all management levels
• Designed and conducted trainee programs on self-leadership and burnout prevention

Freelance Business Coach, Trainer & Organizational Consultant - Self-employed

(2011-02)

Parental leave while establishing a freelance career in coaching and leadership development - Parental leave

(2006-07 - 2011-02)

Head of Licensing / Business Development - ratiopharm GmbH - Ulm, Germany

(1999-07 - 2006-06)

Led the licensing department with up to 18 employees

• Evaluated development and licensing opportunities (regulatory, commercial, patent aspects)
• Conducted international contract negotiations
• Held budget responsibility and signatory authority
• Managed relationships with international partners

Technical Employee in the Regulatory Affairs Department - AAI Germany GmbH & Co. KG - Neu-Ulm, Germany

(1995-04 - 1999-06)

• Prepared and reviewed pharmaceutical dossiers
• Coordinated regulatory development projects
• Managed deficiency responses
• Project management of development products internationally
• Representing the services on international boots

Early Career in Pharmaceutical R&D & Analytics - L.A.B. GmbH & Co., Boehringer Mannheim GmbH and Dr. Renschler Arzneimittel GmbH & Co. - Germany

(1988-09 - 1995-03)

Details available upon request

Technical Employee in the field of method development and analytics of biotechnological products - Boehringer Mannheim GmbH, Werk Penzberg

(1990-09 - 1992-09)

Technical Employee in the field of method development and analytics of biotechnological products as well as cell cultivation from mast cell banks up to manufacturing pharmaceuticals in manufacturing scales.

Dipl.-Ing. - Pharmaceutical Chemistry - University of Applied Sciences Isny (1986-09 - 1990-09)