Regulatory Affairs and CMC Manager

Regulatory Affairs and CMC Manager

ProductLife Group

Mede, Italy

Primary Responsibilities

  • Regulatory strategy planning.
  • Regulatory compliance verification for the products (GLP, GMP; gap analysis).
  • Preparation of response documents to the deficiency letters of health authorities.
  • Preparation and submission of variations to the marketing authorisation, including preparation of the required technical documentation.
  • Revision of site master files, validation master plan, cleaning validation protocols and reports, analytical method validations, manufacturing process validations and holding time validations.
  • Preparation of dossiers in common technical document format.
  • Preparation of active substance master file (ASMF).
  • Provide format and contents review of packaging texts, summary of product characteristics, patient information leaflets and labelling.

Candidate Profile

ProductLife Group applies the principles of equality and diversity in the workplace and opposes all forms of unlawful discrimination.

Education & Experience:

  • Bachelor’s or higher graduate degree in a science related field or equivalent experience.
  • 4-5 years of experience in a similar position.

Skills:

  • Knowledge of EU and Italian registrations.
  • Ability to work well within a team.
  • Good understanding of regulatory tracking database software, EDMS, MS Word, MS Excel.
  • Experience in labelling in Italy.

Other:

  • Good interpersonal skills.
  • Process oriented.
  • Fluent in English and Italian for daily contacts.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Italy     Clinical Research     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Regulatory Affairs     ProductLife Group    

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies