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Regulatory Compliance Manager (Ankara)

Manpower

Ankara

İş Yerinde

İş Yerinde

Job Type

Full-Time

Position Level

Medium Level Manager

Department

Registration

Registration

Application Count

0-50 application

Job Type

Full-Time

Position Level

Medium Level Manager

Application Count

0-50 application

Department

Registration

QUALIFICATIONS AND JOB DESCRIPTION

Our global client is looking for a 'Regulatory Compliance Manager' for their fast growing organization.

The position reports to General Manager.

Responsibilities:

  • As Responsible Pharmacist to support the local company distributor and company Group EU Qualified Persons (QPs) with managing complaints, recalls and returns related to the Turkiye importation and distribution business.
  • Plan, schedule, conduct/assist and report routine or triggered internal and external Good Distribution Practice (GDP) Quality Assurance audits at contracted partners (such as, but not limited to, distributors or licensees) inside Turkiye.
  • Plan, schedule, conduct and review / report (verbally and/or in writing) internal audits of the distributor’s quality management system.
  • Oversee and support CAPA management – evaluation, coordination, follow-up, implementation, recording of evidence of closeout and effectiveness checks - for the Turkiye importation and distribution business.
  • Perform risk assessment and assist in the evaluation of local vendors/third parties, as required.
  • Coordinate, evaluate and follow up responses to QA and QMS audit and GxP inspection findings from regulatory authorities, customers or company group.
  • Analyze deficiencies and deviations (including near misses) to identify areas for improvement and communicate trends to the distributor’s senior management through periodic management review.
  • Maintain a high level of awareness and expertise in Turkiye, EU and regional (Eastern Europe / Balkans) regulatory and applicable legislation requirements.
  • Provide local (Turkiye) expertise and support for process optimization in the main areas of responsibility: Regulatory Affairs and QA to company and distributor management, on request.
  • Lead/host the Turkiye regulatory (TMoH) GDP inspection and respond to inspection observations on behalf of the company as the RP.
  • Support other company's International affiliates and distributors in the E. Europe and MENA region, on request, with respect to inspection-related activities (inspection readiness, mock audit, backroom support, training, response and remediation activities) for GDP.
  • Ensure that all key business processes and their systems for GxP compliance are robust enough to support business continuity and assure continuity of supply of all licensed company products on the Turkish market.


Requirements:


  • Recognised University degree in pharmacy or a medical doctor in Turkiye, (Postgraduate qualification in related subjects - such as radiopharmaceuticals, regulatory affairs or quality- preferred, though equivalent relevant experience will be considered)
  • Fluency in written and spoken Turkish and English is a requirement whilst knowledge of at least 1 another major European language (such as Dutch, French, Greek, Bulgarian or Romanian) would be a distinct asset
  • Minimum 3 years’ regulatory affairs, QMS auditing, QA or other relevant work experience in the Turkish or European pharmaceutical and/or biotech industry
  • Practical knowledge and training in current applicable GxP requirements (eg. GDP) is a requirement
  • Knowledge of managing and setting up controlled document management systems as part of a QMS
  • Personal direct involvement in receiving regulatory inspection (Turkish MoH or other major regulatory authority eg. US FDA, EMA etc.) is an asset

Preferred Candidate

3 - 7 years of experience
Bachelor’s(Graduate), Master’s(Graduate), Doctorate(Graduate)

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