Job ID: 12036

(Senior) Regulatory Affairs Manager (m/w/d)

International pharmaceutical company with headquarter in Munich is looking for reinforcement for their regulatory team. 

Stellenart.

Festanstellung

Ihre Aufgaben.

  • Preparation, review and submission of high-quality Drug Master File and certificate of suitability applications for Active Pharmaceutical Ingredients for submission to European regulatory authorities
  • Review change control and submission of post approval changes to respective Drug Master Files
  • Effective communication with customers to ensure successful product registration by providing open part DMF, technical package and other query responses
  • Assistance to the technical teams in interpreting regulatory status of corrective and preventive action.
  • Involvement in the supplier development with respect to the exact and precise denomination of product specification and registration commitments.
  • Ensuring compliance with regulations set by EU authorities (EDQM, EMA)
  • Planning, undertaking and overseeing product trials and regulatory inspections
  • Preparation, review, filing and maintenance of CEPs (API DMF/CEP submissions)
  • Outlining requirements for labelling, storage and packaging
  • Providing advice about regulations to manufacturers
  • Creation and update of product specifications in line with regulatory and pharmacopoeias requirements.
  • Submission of Regulatory reports like Amendments, annual updates
  • Responsible for updating the CEPs and LoA database

Ihr Anforderungsprofil.

  • Degree: Preference for Chemistry /Medicinal Chemistry/Pharmaceutical chemistry/Biology/Pharmacist degree

  • General Experience:
    2-4 years’ experience across APIs, ideally also in formulations. Knowledge in APIs, pre-formulation and pharmaceutical technology
    Used to work with eCTD software/Extedo

  • RA Requirements:
    Sound experience in GMP, GDP and direct handling of API DMF/CEP filings. While focus for this position is on RA, our QA/RA department works hand in hand. QA understanding is a strong benefit for this position to support the parallel QA function

  • Languages:
    English mandatory, German strongly beneficial
    German work permit necessary

  • Travel: 
    Ability and availability for travels in Europe and abroad (Asia, India)

Vorteile.

  • Working in an international company 
  • Modern workplace in friendly and open working atmosphere with flat hierarchies

Gehalt.

Von: Keine Angabe
Bis: Keine Angabe

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