Beschreibung
Areas of responsibility:- Work in coordination with the Director Regulatory Affairs EU to define and implement pharmaceutical product registration activities according to the OC GRID for EU.
- Compile high quality dossiers for pharmaceutical product registrations according to the strategic development plan.
- Ensure regulatory compliance and maintenance of all pharmaceutical product registrations and licenses throughout the whole life-cycle of the products. Coordinate and prepare timely responses to queries raised by regulatory agencies.
- Develop regulatory assessments and strategies for new pharmaceutical products under development in close coordination with the Director Regulatory Affairs EU.
- Give advice to the EU and the company organization for all regulatory aspects for pharmaceutical products which are of relevance for the oral care products for the Division EU.
- Stay abreast of current and new related pharmaceutical legislation in the region and communicate the impact of changes in the regulatory environment to the Business, and work with the EU RA team to modify the regional strategy accordingly.
- Establish strong relationships within the EU organization and Regional Technology Partners on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, Regulatory and Product Safety, to ensure alignment and synchronization between Regulatory strategies and Business goals
Specific Roles and Responsibilities
- Regulatory Affairs guidance and advisory to Technology.
- Work in coordination with local Legal, Marketing and Supply Chain to address all regulatory concerns.
- Work in coordination with local consultants to support pharmaceutical product registrations for the region.
- Provide regulatory input to product labels and support and review product claims for locally marketed pharmaceutical products.
- Provide category support on day-to-day regulatory issues, new initiatives and developments. Communicate with business and technical partners to shape product development approaches to minimize regulatory impact.
- Obtain clinical trial authorizations for pharmaceutical products/INDs as appropriate
- Obtain appropriate regulatory information to support importation/exportation of Colgate pharmaceutical products. Work in coordination with Logistics to provide cross-border information (such as FSC, GMP certificates, BSE certificates etc.)
- Inform about and/or facilitate governmental inspections for pharmaceutical products as appropriate.
- Ensure a consistent and coherent CP approach to Regulatory Affairs through regional regulatory meetings and on-going work with the EU Regulatory Affairs team.
- Responsible for RA compliance of pharmaceutical product licences and alignment of registration procedures.
- Develop registration strategies for NPD as pharmaceutical products and develop/share best practices within the Pharma Unit.
- Develop and advice on regulatory submission system for pharmaceutical products and development of eCTD dossiers.
Recruitments:
- The position requires a senior person with at least 5 years of experience in regulatory affairs of pharmaceutical product registrations.
- English fluent spoken and written
More Details:
- 12 Months with the Opportunity for an Extension, 80%-100% onsite
- Location: Basel-Area Switzerland
- Start date: a.s.a.p.
For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.
I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.
If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:
Kristina Bröckel
Regulatory Affairs Consultant
Tel:
mailto:
To find out more about Real please visit www.realstaffing.com