Beschreibung
- As a modern company, our client manages to constantly develop further and break new ground.
Regulatory Affairs CMC Associate Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Author high-quality CMC documentation for HA submission with support and guidance applying agreed CMC global regulatory strategies
- Assure 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 health authorities, other database entry activities (specialized department functions)
Main qualifications
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent desirable
- Fluent English required (oral and written) and good skills in German (oral)
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
- Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
- 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
Main advantages:
- A very renowned company
- You will work in an international environment
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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