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Regulatory Affairs Manager

Martigny, Valais, Switzerland · Technical Operations

Description

Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm Research & Manufacturing is a pharmaceutical research, development and production company with GMP facilities certified by the major regulatory authorities. It is the center of expertize for medicinal chemistry for the Group. The company is a world leader in polylactic-co-glycolic acid (PLGA)-based injectables.

Mission

Manage regulatory aspects of future submissions, maintenance and post marketing of drug products including extension of indications in Switzerland, USA and Canada.

Key responsibilities

• Maintenance of DMF drug products in USA and Canada


• Define, develop and lead regulatory strategies for assigned territories


• Coordinate with partners’ regional regulatory teams for global strategy


• Act as liaison with regulatory authorities


• Prepare and Review regulatory submissions


• Maintain policy & regulatory intelligence


• Provide regulatory strategies for manufacturing plans/process projects as RA representative in cross-functional teams

Requirements

Your profile

• Degree in Science (e.g. Chemistry, Pharmacy) or equivalent


• 10 years’ experience in Pharmaceutical regulatory affairs in Switzerland, USA and Canada


• Maintenance, Renewal, Extension of indication


• Pharmacovigilance, DMF; meeting with Health agencies


• Fluent in French, English and German


• Strategic experience for products and experience of Health Authorities meetings


• Fluency in French and English (oral and written), knowledge of Spanish and German is desiderable


• Strong attention to details and organizational skills required


• Good written and oral communication, technical writing and editing skills


• Able to work independently with minimal supervision.