Regulatory Affairs CMC officer

Due to a strong upcoming demand of one of our clients we are looking for 3 Regulatory Affairs CMC officers (temporary position, possible extension).

  • Do you have a Scientific degree and are you fluent in English?
  • Do you have a first experience in the Regulatory Affairs/ Drug development/ Biopharmaceuticals?
  • And are you looking for a career in the RA-CMC department for a leading Pharmaceutical Company?

Then this might be a perfect fit!

Job Description 

Regulatory Affairs is developed from the desire of governments to protect public health, by controlling the safety and efficacy of pharmaceutical products.
It is important for pharmaceutical companies to supply products that are safe and make a worthwhile contribution to public health and welfare.
As a Regulatory Affairs (RA) Professional you play a crucial role in the lifecycle of a medicine, you guide the drug through all phases of development.

Responsibilities 
  • You provide timely preparation of high quality CMC regulatory documentation and contribute to the global regulatory submissions and strategies.
  • You write CMC documentation for Health Authority submissions
  • You apply CMC global regulation strategies and assure technical congruency and regulatory compliance
  • You prepare CMC responses to health authority questions
  • You identify content, quality and/or timeliness issues with source documents
  • You provide support in the annual and product renewal writing, coordination/collection/storage of source documents and are responsible for the submission dossiers to the Health Authorities
  • You actively participate as a member of the global Regulatory CMC team, by contributing to the regulatory strategy, identifying the critical issues and establishing working relationships with partners and customers.
Profile 
  • You have a Scientific degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, ...)
  • You have an excellent level of English (oral and written)
  • You have a first experience in the Regulatory Affairs/ Drug development/ Biopharmaceuticals
  • You are able to critically evaluate data from a broad range of scientific disciplines
  • You have a good knowledge of the drug development processes and the product life cycle regulations
  • You are able to work in a multinational setting and coordinate multiple projects
  • You are stress resistent and have strong organizational skills
  • You have excellent communication and negotiation skills
Contact Information 

Ellie Depape
Talent Acquisition Associate
t +3215 21 11 04
m ellie.depape@valesta.com

Application form : Regulatory Affairs CMC officer

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