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For our client in Basel we are looking for a Regulatory CMC Associate Manager for a 3 month contract. Place: Basel
Period: ASAP- 16.12.2016
Workload: 100% Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
1. Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project life cycle.
2. Prepare CMC responses to health authority questions during development, registration and product life cycle.
3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
7. Establish and maintain sound working relationships with partners and customers.
8. Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Key Performance Indicators (Indicate how performance for this job is measured)
1. Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate documentation on matters within CMC control.
2. No last minute source document issues identified that could have been prevented by early review of source documents.
3. Ensure that CMC regulatory documentation follows guidelines and meets regulatory guidelines, as appropriate (eg measured by approval of CMC documentation, and no non-approvals due to CMC issues under our control).
4. Positive customer feedback. Ideal Background Education (minimum/desirable):
Minimum: Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
Languages: Fluent English required (oral and written). Good skills in site (local) language desired (oral)
1. 0-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
2. Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
3. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
4. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
5. Effective planning, organizational and interpersonal skills.
6. Reasonable approach to risk assessment.
7. Excellent written/spoken communication and negotiation skills.
8. Computer literacy. For more information, please contact: Moritz Dewald (see below).
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