stephanie sommer

stephanie sommer

global regulatory affairs manager

About

Invitrogen. Technical Services Representative ... Attended a comprehensive course in Traditional Chinese Medicine including acupuncture, herbal therapies, and tuina (Chinese massage). ... Director, Global Regulatory Affairs at Merck Serono...

Country

germany

City

frankfurt

Industry

pharmaceuticals

Skill

drug development, clinical research, regulatory requirements, ectd, regulatory submissions, regulatory affairs, ich gcp, protein chemistry, purification, market access, medical writing, gmp, pharmaceutical industry, clinical trials, clinical development, fda, pharmacovigilance, biotechnology, gcp, lifesciences, sop

Experience

lundbeck

regulatory affairs specialist

lundbeck

2009-1 - 2012-10 · 3 yrs 10 mos
schwarz pharma

medical writer

schwarz pharma

2006-1 - 2008-1 · 2 yrs 1 mo
ucb

medical writer

ucb

2006-6 - 2008-12 · 2 yrs 7 mos

Authored clinical submission documents including Phase I through III study reports, Investigator's Brochures, and summary documents. Facilitated decision-making processes in an international and interdisciplinary team environment. Experience in electronic document management systems.

life technologies

technical services representative

life technologies

2003-1 - 2006-1 · 3 yrs 1 mo

Provided pre- and post-sales technical support for the entire product portfolio to customers in German-speaking regions.

boehringer ingelheim

global regulatory affairs manager

boehringer ingelheim

2012-11 - Present · 13 yrs 11 mos

For more than 130 years, Boehringer Ingelheim has been committed to the research, development, and manufacturing of new medications with high therapeutic value for people and animals. As a family-owned pharmaceutical company, Boehringer Ingelheim is able to take a long-term view and invest heavily in research and development. We are proud of addressing some of the most challenging healthcare issues. Our vision – value through innovation – has always characterized our collaborative work, and is for us simultaneously a fundamental requirement and a driving force. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. For more information please visit www.boehringer-ingelheim.com

Education

kiel university

kiel university

biology

1988-1 - 1994-1 · 6 yrs 1 mo
tianjin university of traditional chinese medicine

tianjin university of traditional chinese medicine

chinese

1998-1 - 2000-1 · 2 yrs 1 mo

Attended a comprehensive course in Traditional Chinese Medicine including acupuncture, herbal therapies, and tuina (Chinese massage).

universität zu lübeck

universität zu lübeck

molecular biology

1995-1 - 1998-1 · 3 yrs 1 mo

Established an expression and purification system for human Vigilin (a KH-domain protein) for RNA-protein interaction studies.

baylor college of medicine

baylor college of medicine

2000-1 - 2003-1 · 3 yrs 1 mo

Performed research on the clinical relevance of an SNP in the estrogen receptor alpha (retrospective study) and on the mechanism of regulating the expression of non-receptor type tyrosine kinase c-Yes.

stephanie sommer's Contact Information

Email

******@***.com

Phone

(**) *** ****

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