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11565en
- Contract
- English
- Associate
- Research & Development
- Bern
- Healthcare & Life Sciences
Skills
Regulatory Affairs, Clinical Trials, Pharmaceutical, Clinical Trials Applications, ICH guidelines, GCP
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About our client
Our client is one of the leading international pharmaceutical companies based in the Bern area.
On behalf of our client, Swisslinx is seeking a highly motivated individual to take on a challenging temporary role in their Regulatory Affairs department.
This is a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
Your mission:
- Creating CTA submission strategy for Clinical Trials and preparing and approving CTA dossier
- Reviewing key documents such as, but not limited to CSP, IB, IMPD, IMP labels, DSUR
- Improving processes, procedures and systems which support the global management of CTAs
- Ensuring timely and accurate handling of CTA activities in the appropriate systems
- Managing and leading the Regulatory Execution Team
- Acting as the primary point of contact for stakeholders outside of Regulatory Affairs, collaborating with diverse departments
- Supporting budget development and management related to CTA activities
Your background
- Minimum 5 years of professional experience in managing Clinical Trial Autorizations
- Bachelor’s degree in Pharmacy, Life Sciences or another medical realted area
- Excellent knowledge of ICH guidelines/GCP and current medical regulatory knowledge
- Fluency in English is a must, any additional language is beneficial
Our client is one of the leading international pharmaceutical companies based in the Bern area.
On behalf of our client, Swisslinx is seeking a highly motivated individual to take on a challenging temporary role in their Regulatory Affairs department.
This is a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
Your mission:
- Creating CTA submission strategy for Clinical Trials and preparing and approving CTA dossier
- Reviewing key documents such as, but not limited to CSP, IB, IMPD, IMP labels, DSUR
- Improving processes, procedures and systems which support the global management of CTAs
- Ensuring timely and accurate handling of CTA activities in the appropriate systems
- Managing and leading the Regulatory Execution Team
- Acting as the primary point of contact for stakeholders outside of Regulatory Affairs, collaborating with diverse departments
- Supporting budget development and management related to CTA activities
Your background
- Minimum 5 years of professional experience in managing Clinical Trial Autorizations
- Bachelor’s degree in Pharmacy, Life Sciences or another medical realted area
- Excellent knowledge of ICH guidelines/GCP and current medical regulatory knowledge
- Fluency in English is a must, any additional language is beneficial
