Regulatory Cmc Operations Manager

2 semanas atrás

Leiria, Leiria, Portugal NonStop Consulting Tempo inteiro

Location:

  • Leira, Portuguese areas, Portugal
  • Salary:
  • Bonuses and Benefits
  • Type:
  • Permanent
  • Main Industry:
  • Search Health, Nursing & Social Services Jobs
  • Advertiser:
  • NonStop Consulting
  • Job ID:
  • Posted On:
  • 07 March 2023
I am actively seeking a Regulatory CMC Operations Manager for a medium-sized pharmaceutical company who is rapidly growing.


This strategic position is ideal for someone who thrives in a hands-on environment, and loves to challenge themselves, while growing with the company to develop their career even further.


In this hands-on position you will be working closely with and receive support from senior members of staff including the VP of Regulatory Affairs to develop and grow your skills and knowledge while utilising your current skill-set.


My client is also open to applicants anywhere in the EU, so this is a great opportunity to relocate to the beautiful Switzerland.

Your tasks

  • Compiling regulatory documents (e.g. clinical trial regulatory dossiers, client data packages, DMFs) in line with regulatory requirements and customer's requests, according to the defined timelines
  • Developing dossier content strategies
  • Answering deficiency letters from Authorities
  • Performing regulatory assessment of changes as part of GMP change control
  • Preparing regulatory documents to support postmarketing changes (e.g. "Variations") and submitting them accordingly, where applicable
  • Providing regulatory advice to and answering regulatory questions from internal and external customers, throughout the product lifecycle (including development)
  • Defining, communicating and keeping RArelated timelines for his/her projects
  • Representing RA in project teams for NCEs

Profile:

  • PhD in chemistry
  • Fluent in English (German is a bonus)
  • Experience in Regulatory Affairs


If you are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or below and get a head of the crowd I look forward to hearing from you.


For a confidential discussion about this role, or, then send your CV to # or call me, Corey Buckley, Recruitment Consultant - Life Sciences - Switzerland, at intern Please feel free to visit my Linked-in profile to see my references/recommendations.

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.

Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across

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