Senior Specialist - Regulatory CMC - REMOTE

Lifelancer


Date: 5 hours ago
City: Remote, Remote
Contract type: Full time
Remote
Your Role:

  • Ability to contribute to the dossier content and to support the life cycle management of regulatory Devices and Drug/Device combination activities.
  • Ability to develop, prepare and implement successful regulatory strategies and dossiers.
  • Experience in preparation and management of regulatory documentation, including full global submission roll outs (new product application) or large variations for medical devices and/or drug device combination products.
  • Experience with life-cycle management activities within the medical devices and drug/device combination products including prefilled pens, electronic autoinjectors and pre-filled syringes in the EU/US and International markets.
  • Understanding and awareness of global pharmaceutical and medical device legislation
  • Awareness of regulatory affairs contribution to Pharma business
  • Basic understanding of concepts of project management and Regulatory affairs
  • Good written and spoken English communications.
  • Ability to think strategically, to perform root cause analysis and to propose and drive continuous improvement.
  • Normal and routine office duties (hours of work may be adapted to match the Global team in EU and US region)
  • Position may require both domestic and international travel.


Who you are:

Education

  • Degree in a Life Science related disciplines, Pharmacy, preferably higher degree (e.g., MSc in scientific discipline or M. Pharm or Masters in Regulatory affairs)


Work experience:

  • 7-10 years of overall work experience in Pharma environment
  • Competent authority or Academia/R&D experience related to the role.
  • Minimum 5 years of experience in regulatory affairs in medical devices and drug/device combinations.


Please apply on the Lifelancer platform at the below link for screening steps & quicker response.

https://lifelancer.com/jobs/view/42beadceddec265db65bc77ace4b669b

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