K-RECRUITING Life Sciences Personalberatung - flip image

Tasks:

Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies
Author 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)

K-RECRUITING Life Sciences Personalberatung - box background image

Qualifications:

Start: 18.01.2021 // Duration: 12 months // Capacity: Full-time
Bachelor's Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
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
Business fluent in English

Regulatory Affairs CMC Manager

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