Quality/ Regulatory Manager

Vor 3 Tagen

Schweiz NonStop Consulting Vollzeit

NonStop Pharma is currently recruiting a Quality/ Regulatory Manager for a well established pharmaceutical affiliate based here in Switzerland. This company has been rapidly growing over the past few years through many successful product launches. As recently they have grossed over 700,000,000 in revenue. Here you will be a part of a stable team of 12, this small team dynamic creates a much more approachable team dynamic and office atmosphere.
This extremely versatile position will make your professional practice much more exciting. Here you will have a range of duties outlined Regulatory Affairs, QPPV, Medico Marketing, and QP.

**Some Of The Activities Outlined In The Job Description**:
1. QP
Legal duties and responsibilities as defined in CH and EU directives
Maintaining and managing GMP/GDP Quality System (covering pharmaceuticals, medical devices, cosmetics and nutritional)
Market Release for Swiss market
2. QPPV
Legal duties and responsibilities as defined in CH and EU directives
Maintaining and managing vigilance System in unity with Global safety (covering Pharmaceuticals, medical devices, cosmetics and nutritional)
Expanding PV system to meet increasing HQ requirements-local PSMF
Risk Management (PSURs, Signal management)
Managing PV audits and inspections (from authorities and from Global Safety)
Acting as single contact for health authorities (24/7 availability)
3. Regulatory Affairs
Review, preparation and submission of dossiers for new MAs
Packaging approvals and submissions
Correspondence with authorities (Swissmedic / BAG)
Pricing strategy and submission for reimbursed products
Close direct cooperation with regulatory department HQ in France
Preparation of scientific documents in compliance with local regulations
4. Medico Marketing
Named person responsible for marketing material approval
Review and approval of medico marketing material
Medical and Scientific information support
Training of Medical Reps and internal staff.

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