vor 8 Tagen auf harveynash.ch

Regulatory Affairs CMC Associate Manager

Harvey Nash AG

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Regulatory Affairs CMC Associate Manager

For our client in Basel we are looking for a Regulatory Affairs CMC Associate Manager for a 9-month contract.

Duration: 01/03/2019 to 20/12/2019

Location: Basel

Workload: 100%

Job Purpose: 
Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies. 

Major Activities: 
• 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 lifecycle. 
• Prepare CMC responses to health authority questions during development, registration and product lifecycle. 
• Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 
• 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. 
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. 
• Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. 
• Establish and maintain sound working relationships with partners and customers. 
• 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). 

The candidate’s profile:
Education: 
• Minimum: Degree in Science (e.g. 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) 

Experience: 
• Regulatory experience preferred, and/or experience in drug/biopharmaceuticals 
• 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. 
• Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. 
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload. 
• Effective planning, organizational and interpersonal skills. 
• Reasonable approach to risk assessment. 
• Excellent written/spoken communication and negotiation skills. 
• Computer literacy 

For further details please contact Beata Arciszewska:
email: beata.arciszewska@harveynash.com
tel: +41435088640