Regulatory Affairs CMC Associate Manager (m/f/d)

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Beschreibung


  • One of the biggest pharmaceutical company of the world 

Regulatory Affairs CMC Associate Manager (m/f/d)

Reference: -en
Start: asap
Duration: 12 MM++

Main tasks:
  • 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 strat-egy, 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)


Main qualifications
  • Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
  • Fluent English required (oral and written) and Good skills in site (local) language desired (oral) (German)
  • 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


Main advantages:
  • You will work in an international environment
  • Option for extension



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.

My contact at Hays:

My contact person:
Natascha Hanser

Referencenumber:


Make contact:
Email:
Start
ab sofort
Dauer
12 MM++
(Verlängerung möglich)
Von
Hays AG
Eingestellt
26.09.2020
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1974277
Vertragsart
Freiberuflich
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