Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. Email and Phone Number

Vice President, Regulatory Strategy @ SSI Strategy
Munich, BY, DE
Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s Location
Greater Munich Metropolitan Area, Germany, Germany
Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s Contact Details

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. work email

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. personal email

n/a

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. phone numbers

About Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. is a Vice President, Regulatory Strategy at SSI Strategy. They possess expertise in strategy, regulatory affairs, pharmaceutical industry, project management, biotechnology and 18 more skills. They is proficient in French. Colleagues describe them as "Anna is not just smart, talented, organised and great to work with, but she stands out from the crowd. We worked together on the same team on a very fast-moving development programme. Very soon after she joined the company and the team, she was instrumental to the delivery of regulatory advice from EMEA under extremely tight timelines. She led and managed the whole process successfully. She demonstrated outstanding leadership skills, initiative, integrity and strong project management skills from start to finish. We continued collaborating on other regulatory initiatives within the same programme, where Anna consistently performed very professionally and efficiently. Anna is a hard-working, ethical, motivated and efficient team member, very trustworthy and personable, a pleasure to work with. Anna is an expert in her field and having closely worked with her for over a year, I also had the opportunity to learn a lot from her. She will be an asset to any team that she joins." and "I wish to express my highest recommendation for Anna Limpert. Her ability to manage her projects has been outstanding. I have been consistently impressed by both Anna's attitude towards her work and her performance on the job. Anna was also highly respected by the people who work with her within the company as well as by external business partners. She possesses a strong knowledge in the field of regulatory affairs and is always looking to gaining even more knowledge. She has the analytical skills to diagnose problems and devise viable solutions. Anna would be a tremendous asset for any company."

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s Current Company Details
SSI Strategy

Ssi Strategy

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Vice President, Regulatory Strategy
Munich, BY, DE
Website:
ssistrategy.com
Employees:
176
Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. Work Experience Details
  • Ssi Strategy
    Vice President, Regulatory Strategy
    Ssi Strategy
    Munich, By, De
  • Daiichi Sankyo Europe Gmbh
    Senior Director, Global Regulatory Lead
    Daiichi Sankyo Europe Gmbh Apr 2022 - Present
    Munich, De
  • Daiichi Sankyo Europe Gmbh
    Director Regulatory Affairs/Regulatory Strategist
    Daiichi Sankyo Europe Gmbh Jun 2017 - Apr 2022
    Munich, De
    EU Regulatory Lead and global regulatory clinical study lead for an innovative, multi-indication biologic drug in the oncology field. Excellent track record in global drug development and fast to market regulatory strategies. Key interests include: - shaping the EU regulatory landscape regarding innovative approaches to licensing drugs especially in the oncology field- bridging clinical development and market access to establish fast to market strategies for medicinal products that meet unmet medical needs-how the use of artificial intelligence and machine learning will alter the regulatory landscape and can aid in drug development
  • Bristol-Myers Squibb
    Associate Director Eu Regulatory Strategy
    Bristol-Myers Squibb Jan 2015 - Jun 2017
    in Addition to my local responsibilities for the BMS Oncology Portfolio, I started taking up EU-wide regulatory responsibilities for BMS assets. I have made the Transition to the EU HQ work fully at the beginning of 2016.
  • Bristol-Myers Squibb
    Manager Regulatory Sciences Germany And Switzerland
    Bristol-Myers Squibb Jan 2011 - Dec 2015
    All about Regulatory Affairs: Launch Readiness and Preparation, Life Cycle Management of Medicinal Products, Value Dossier compilation/writing, Interaction/Negotiation with Health Authorities
  • Bencard Allergie Gmbh
    Regulatory Affairs, Cmc Specialist
    Bencard Allergie Gmbh Sep 2009 - Jan 2011
    Writing and Compiling EU Marketing Authorization Application Dossiers (CTD, eCTD): From laboratory notebook and printouts of R&D scientists to a full CTD Module 3 and 4, including QoS and Preclinical Summary. Submission of MAAs: From data to submission strategy to submission execution: MRP, EU MAAPortfolio Management: Using Regulatory Strategy to manage portfolio and respond to changes in EU legal frameworks, pricing freezes and marketing restrictions.Health Authority Interactions: Connecting company and health authority - executing and fostering productive collaborationInspections/Audits: Leading and supporting GMP, GCP and PV inspections, starting an inspection readiness initiative focused on GMP inspections by health authorities
  • Essex Pharma Gmbh München
    Regulatory Affairs Manager
    Essex Pharma Gmbh München Apr 2008 - Sep 2009
    Regulatory Affairs Manager in a multinational pharmaceutical company: handling an array of regulatory topics from the "Nachzulassung" (German Legacy National MAs), Life Cycle Management for biotech products to current marketing authorizations and regulatory launch readiness for new products.
  • University Of Tuebingen
    Group And Laboratory Leader, Postdoctoral Researcher
    University Of Tuebingen Apr 2005 - Mar 2008
    Leader of a Team of 7 scientists/technicians. - Research Topic: Oxygen sensing of the pathogen Pseudomonas aeruginosa. Identification of a novel oxygen sensory network that might have relevance in sustaining hospital-acquired infections with this pathogen. - Production of diagnostic antibodies (GMP conform contract manufacturing)-Supervising doctoral students (biologists, biochemists)- Training of medical and pharmaceutical sciences students,- lectures and labs in microbiology and hygiene, lectures in microbial and human genetics

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. Skills

Strategy Regulatory Affairs Pharmaceutical Industry Project Management Biotechnology Leadership Regulatory Strategy Drug Research And Development Business Development Management Cmc Drug Development Business Strategy Gmp Clinical Trials Oncology Life Sciences Good Clinical Practice Clinical Development U.s. Food And Drug Administration Product Launch Regulatory Submissions Market Access

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. Education Details

  • Stanford University Department Of Chemistry And Biochemistry
    Stanford University Department Of Chemistry And Biochemistry
    Host-Pathogen Interactions
  • Duke University School Of Medicine
    Duke University School Of Medicine
    Drug Development
  • The University Of Bonn
    The University Of Bonn
    Drug Regulatory Affairs
  • Leibniz Universität Hannover
    Leibniz Universität Hannover
    Biochemistry/Molecular Genetics/Microbiology

Frequently Asked Questions about Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.

What company does Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. work for?

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. works for Ssi Strategy

What is Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s role at the current company?

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s current role is Vice President, Regulatory Strategy.

What is Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s email address?

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s email address is an****@****bms.com

What is Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s direct phone number?

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s direct phone number is +1 800-321*****

What schools did Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. attend?

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. attended Stanford University Department Of Chemistry And Biochemistry, Duke University School Of Medicine, The University Of Bonn, Leibniz Universität Hannover.

What skills is Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. known for?

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D. has skills like Strategy, Regulatory Affairs, Pharmaceutical Industry, Project Management, Biotechnology, Leadership, Regulatory Strategy, Drug Research And Development, Business Development, Management, Cmc, Drug Development.

Who are Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s colleagues?

Dr. Anna Silke Hammerbacher, M.Sc., M.D.R.A., Ph.D.'s colleagues are Jesse Alexander, Ramesh Arjunji, Phd, Benjamin Konop, Lisa Campbell, Dr. Len Walt Md, Mba, Robert Bwire, Samantha Baby.

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