Post by abarcelo on Sept 14, 2015 14:27:15 GMT
Regulatory Affairs Project Manager (103741)
-Company:
Merck Serono
-Location:
Darmstadt, Germany
-Job Status/Type:
Full Time, Employee
-Job Category:
Biotech/ R&D/ Science
-Industry:
Biotechnology/ Pharmaceuticals
-Work Experience:
beginners accepted
-Education Level:
Higher degree in Life science
-Date of publication : 09/14/2015
KEY TASKS & RESPONSIBILITIES
Preparation of regulatory documentation and management of regulatory submissions to the ICH regions and international regions in cooperation with an external vendor. Member of the Regulatory Subteam. Close cooperation with headquarter and country regulatory affairs functions in Europe and international countries. You will be working in all geographical regions worldwide with global project teams, i. e. Supply Chain, Medical Affairs, Clinical Pharmacology and third parties vendors.
CANDIDATE’S PROFILE
• Degree in a Life Science or related discipline, higher degree preferable (e.g. PhD, MSc, MBA)
• Fluent in spoken and written English
• Good interpersonal, team work and project management skills
• Attention to details
• Ability to work in multi-cultural and cross-functional teams
• Strong goal- and solution-orientation combined with responsibility, initiative and perseverance
• Minimum of 2 years’ industry experience of which at least 1 years’ regulatory experience
• Experience in preparation and submission of dossiers in at least one ICH region, the preparation of documents for regulatory agency interactions, regulatory maintenance activities for authorizations in a local affiliate or head office and as a member in project teams.
• Experience in Regulatory Affairs in the International Markets
• Project Management experience
Company profile: Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
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