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Job

Regulatory Affairs Manager

  • Location

    Berlin (Remote Option Available)

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Sandeep Bains

  • Contact email:

    s.bains@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2022-01-10

  • Startdate:

    ASAP

Hamlyn Williams has partnered with a rapidly expanding pharmaceutical company based in Berlin. This global pharmaceutical firm is currently in a major phase of growth due to its innovative and expansive pipeline, and are looking for a Regulatory Affairs Manager on a permanent basis. 

The role will involve but not be limited to:

  • Preparation of regulatory submissions, this would include the evaluation of analytical, manufacturing, pre-clinical and clinical data.
  • When required preparation of CTD, DMF, QOS, SmPC
  • The successful candidate would be responsible for the drafting, compiling and controlling of the quality and regulatory dossiers for product registration 
  • Document collecting and reviewing - the incumbent would be leading this activity and responsible for the adherence to applicable regulations in line with the submission and review teams
  • Conduct the regulatory impact assessment of CMC changes to ensure compliance with the relevant regulations

As a Quality Assurance Manager you will need:

  • Several years of professional direct regulatory experience in drug development/ regulatory affairs or other healthcare related fields  
  • Experience of working within a pharmaceutical manufacturing, packaging and warehousing cGMP Quality Management System 
  • Adept knowledge and experience in regulatory submissions 
  • Fluent in English and German
  • Confident handling of MS Office
  • Knowledge and understanding of EU regulations as well as being able to interpret the policies and guidelines  

I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the pharmaceutical and biotechnology industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Sonny at +44 020  8164 5340 or at s.bains@hamlynwilliams.com.

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