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Job Details
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RA CMC & Technical CMC Specialists - International Pharma Group



Business Type: Pharmaceutical Company, Drug Development Company
Job Type: CMC, Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Salary: Negotiable
Location: Italy
Reference: PC.69059.2
Closing Date: 29/07/21
Job Details:

NonStop Pharma is currently looking for a Regulatory Affairs Technical CMC Specialist and a CMC Specialist to join an International Pharmaceutical Group, dedicated to the research, development, manufacturing and marketing of innovative pharmaceuticals, including a specialised business dedicated to treatments for rare diseases.

Technical CMC Specialist:

Experience:

  • Writing and managing technical sections of Module 3 (and IMPD) in collaboration with relevant departments
  • Assessment of documentary/technical gaps associated with existing products, processes and methods (Gap Analysis)
  • Evaluation of technical reports (Process Validation Protocols & Reports, Analytical Methods Validation, AMT, Development Reports) and who also knows how to translate these reports into regulatory documents suitable for submission to the Regulatory Authorities
  • Verification (with critical vision) of Modules 3 of existing products in order to predict the potential future regulatory impact associated with those products and related variations

Knowledge:

  • CMC sector, such as ICH Q, EMA Quality guidelines, WHO guidelines

Regulatory Affairs CMC Specialist

Responsibilities:

  • Contribute to active ingredients registration, manufacturing site authorisation and maintenance of regulatory sections of existing authorization
  • Assess and complete Module 3 compliance with law and relevant regulations
  • Define priorities and timelines for the above activities based on a risk assessment
  • Provide regulatory support in preparation and during inspection;
  • Support the Regulatory Product Responsible in providing robust regulatory advice and plans to the concerned internal functions and extramural stakeholders to ensure the timely implementation of regulatory activities in order to meet the business needs.
  • Participate to project/product-related discussions and provides in-depth strategic, scientific and RA input, for technical and procedural aspects of a given project.
  • In collaboration with other functions define the key messages for product/portfolio specific regulatory documents to be submitted to Authorities

Candidate''s profile:

  • Degree in….Ph.D. or M.D in Pharmacy, Chemistry, Biology or Medicine.
  • At least 4+ years significant experience in CMC regulatory affairs.
  • Fluent in English, with excellent writing skills.

If you want to play a key role in an International Pharmaceutical group, with a direct presence in the US, Europe and Asia, submit NOW your CV to Patrick Carignano - p.carignano@nonstop-recruitment.com

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. We have a strong presence within Italy as well as Germany, Switzerland, France, The Nordics and Benelux. Please visit our website for a full list of the niche markets we cover.



Posted: 22/07/2021 | NPJ Ref: 276185
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