Regulatory Affairs Manager

VaudFixe2018-08-30Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Regulatory Affairs Manager

Responsibilities:

• Manage post marketing regulatory activities of drug products including extension of indications in
Switzerland, USA and Canada.
• Maintenance of Swiss registration files
• Maintenance of DMF drug products in USA and Canada
• Coordinate with partners' regional regulatory teams for global strategy
• Act as liaison with Swissmedic
• Define, develop and lead regulatory strategies for assigned territories
• Prepare and review regulatory submissions
• Internal Regulatory contact for Pharmacovigilance and Marketing for Switzerland
• Maintain policy & regulatory intelligence
• Provide regulatory strategies for projects as RA representative in cross-functional teams

Profile:

• Degree in Science (e.g. Chemistry, Pharmacy) or equivalent
• 10 years' experience in Pharmaceutical regulatory affairs in Switzerland, USA and Canada for sterile parenteral drugs
• Maintenance, Renewal, Extension of indications,
• Previous experience in meeting with Health agencies,
• US and Canada Regulations for DMF;
• Strong attention to details and organizational skills required
• Good written and oral communication, technical writing and editing skills

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La référence de cette offre est JN -082018-293402 - HAID

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