Manager Regulatory Affairs & QA - APIs & FDFs (m/w/d)

Ort: München, Bayern, Deutschland
Gehalt: a. A.
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
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Manager Regulatory Affairs & Quality Assurance APIs & FDFs (m/w/d)

This position is to be filled full-time (40 h/week).

This tasks are awaiting you:

Focus on Regulatory Affairs:

  • technical position in * FD product development and pipeline selection team
  • support regulatory activities and set regulatory strategy and policy for regulated products
  • support the company's partners in compiling, submitting, and up-keeping of regulatory
  • submission (EU eCTD publication; DCP, MRP, NP)
  • global regulatory life-cycle management
  • act as a Regulatory Agent
  • collaborate and support strategies for interactions with regulatory authorities, point of contact for Health Authorities (scientific advice meetings)
  • lead the RA/QA departments due diligence activities in support of product development
  • and/or regulatory submissions as applicable
  • correspond and interact with customers and regulatory agencies during audits of the company
  • provide Quality Assurance and Regulatory Affairs operational support

Focus on Quality Assurance:

  • create, review, maintain and track Standard Operating Procedures for compliance with GMP and GDP regulatory requirements, guidelines and industry standards
  • train employees on SOPs, GMP, GDP and quality related matters
  • organize and supervise the execution of the QMS
  • coordinate and participate during the assessment and evaluation of suppliers, CMO's, CDMO's and other service providers of the company
  • conduct audits and assist with regulatory inspections, follow up on audit responses and assist in verifying CAPA effectiveness
  • compilation and establishment of technical agreements/quality agreements
  • record, administer and follow up deviations, customer complaints, and change control
  • review, analyse, and recommend approval for data generated from manufacturers and/or laboratories to ensure that the products and processes, raw materials, components and validations, are appropriately analysed, documented and approved/released
  • release APIs and other products which need not to be released by the company's QP
  • act as a Wholesale Responsible (Großhandelsbeauftrage/-er)

What you need to get startet:

  • Natural scientific background (Chemistry /Medicinal Chemistry/Pharmaceutical
  • chemistry/Biology/Pharmacist degree)
  • Min 5 years, ideally 10 years' experience across APIs, ideally also in Formulations
  • RA experience: both in API and FDF (DMF/CEP submissions and FDF registration management such as DCP, MRP or NP registrations, EU eCTD publication)
  • FDF experience and knowledge, with focus on generics
  • QA experience: for both API/Formulations: General knowledge in API, Preformulation and pharmaceutical technology. General knowledge and experience in cGMP, GDP, ICH, QA system, internal compliance and SOP's document drafting, as well as API QA releases. Very good understanding of key business processes within supply chain, product lifecycle processes. Experience as a Wholesale Responsible (Großhandelsbeauftrage/-er)
  • Audits: Ability to perform and compile audits of API factories and FD production sites to ensure the compliance of our suppliers. Support to customers and suppliers of API and FDF. Ideally certified auditor.
  • Fluent in German and English
  • Availability for travels in Europe and abroad (Asia, India)

Your contact person for this position is Ms Franziska Mayr

You can reach her directly at:

T: +49 (0)89 5519 7774

M: f.mayr(at)progressive.de

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