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Regulatory Affairs Consultant CTR - Prague

Parexel International Corporation

Czechia, Remote

We are looking for a Regulatory Affairs Consultant CTR with experience in EU CTR to be based in Czech Republic. This role can be either home or office based.

In this role you will work closely with other departments to design, implement applications & systems to support regulatory business processes. You will be the Regulatory Leader responsible for Part 1 submissions - therefore global RA, RL experience with knowledge in EU CTR is essential

Role Responsibilities:Performs submission management activities for assigned protocols.  Partners with study teams, is responsible for managing the required regulatory activities and  CTA submission delivery in multiple countriesYou will be the Regulatory Leader responsible for Part 1 submissions - therefore global RA, RL experience with knowledge in EU CTR is essential Acts as Regulatory SME for CTAs for Prague and other countries in the regionAdvises on submission strategy for the region and assess the associated impact of submission delivery activities in the region and leads/attends relevant meetings to advocate realistic deliverable timelines and strategyLiaises with Core team, SSU and Study Management, regarding the needed documentationPrepares, reviews and submits CTAs to Health Authorities in Prague and other European countries in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conductEnsures high quality submissions are performed, compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelinesEscalates, informs, and resolves any issues that may impact submission builds or the logistics of submission delivery across the region

Ideal candidate will possess:

• BS/BSc in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.​

• Experience in Regulatory Affairs and Clinical Research  (5+ years) 

•A background in clinical trial management with a specific focus on EU CTR

• Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization , and training.

• Project Management experience

• IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI…)

• Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.

• Customer-oriented and autonomous

• Fluency in English is a must along with the local language.

You will be rewarded with a competitive salary and benefits package! And we can offer extensive career development within our growing Regulatory portfolio.

#LI-REMOTE

Job posted: 2022-12-08

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