Regulatory Operation - Training for International Career

My client is a well known consultancy company in the Hessen Region, who is currently looking for a new Regulatory Information Manager (m/w), who will take care of the international submissions from the eCTD side.

The company is very willing to provide own employers with training, in order to sustain their further career development. As the company has offices and clients all around the world, this can be a very good chance to kick off your career on international level ! If you feel interested in principle, feel free to contact me.

Your tasks:

• Preparation of electronic submissions in eCTD format for international registrations in EU and USA
• Creation and validation of electronic submission for all regulatory activities (e.g. MAAs, PSUR, amendments, variations, renewals)
• Development of eCTD strategy
• Taking part to the validation and maintenance tasks for DocuBridge

Your requirements:

• Solid experience in creation and validation of submissions in eCTD format for all regulatory activities
• English on business level

Nice to have: German language skills

Contract Type: Permanent, Full Time

Location: Munich or Berlin or Frankfurt

Starting Datum: ASAP, but the client is willing to come toward to your needs

Salary: Negotiable on experience basis

If you feel interested in principle, write or call me: E.Fleury@nonstop-recruitment.com / Dr Emma Fleury, 0049 892 109 33 63.

If you want to apply, just sent your CV IN WORD.DOC FORMAT to my email address.

Happy to recommend someone? If we manage to place your referral, you will get a small thank you gift.

Please be aware that, due to the high number of application, we could be not able to provide you with feedback, if your profile is too much distant from the one described above.

Key Words

Regulatory Operations, Information Technology, XEVMPD, IDMP, NeeS, eCTD, SOPs, WIs, electronic submission, quality assurance, Pharma, consultancy, consultant, growing company, growing