Regulatory Cmc Operations Manager - Barcelona, España - NonStop Consulting

NonStop Consulting

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

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 time-lines
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 post-marketing 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 RA-related 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

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