Clinical Trial Regulatory Affairs Specialist
Encontrado en: beBee S ES - hace 4 semanas
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
Clinical Trial Regulatory Affairs Specialist
The Clinical Trial Regulatory Affairs Specialist will be responsible for providing expert support for compilation, publishing and submission of the EU Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
Duties & Responsibilities:
Support EU Clinical Trial Application: support the European submission management activities and partnering with product teams, follow the regulatory strategy, facilitate the gathering of or draft core documents to be included in the clinical trial application (Part 1), ensure preparation and collection of additional regional administrative documents (Part 2), interact with a cross-functional team to exchange of Trial Related Documentation and Information, ensuring the completeness of the CTA package, review the complete draft CTA documentation for completeness and accuracy of the single documents included, ensure high quality components and submissions are compliant with industry guidelines and regulatory strategies. Ensure that the required regulatory intelligence is in place to comply with CTR requirements. Fill in the EU portal database and facilitate the upload of the CTA package, ensure that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system, support archiving of the CTA submission package.Support of Post Approval Activities: coordinate compilation and submit answers to health authority questions/Ethics Committees including provision of regulatory guidance on the interpretation of the health authority questions, compile and upload to the EU portal Substantial CTA Amendments, support of archive the amendment submission package, support of notification of the end of a clinical trial, and Submission of clinical trial (summary) reports.Support of clinical trial activities: enter and track submission and approval events in RIM system (clinical trial database), liaise with the sTM RA Manager and local units in coordinating and answering health authority questions, be the primary contact point between Regulatory and the EU CTR Portal for the management of submissions of CTAsProfile and requirements:
Minimum of a bachelor’s degree in a Scientific, Healthcare, or related experience with pharmaceutical or health sciences industry; knowledgeable with scientific terminology.Advanced degree (e.g., Master or Postgraduate) would be an asset.At least 2 years of pharmaceutical industry experience in Regulatory Affairs – CTA is required.Excellent English written and conversation skills are required along with strong interpersonal and consultative skills.Work experience in international regulatory affairs, preferably also covering EU regulatory procedures.An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements. Good understanding of chemical, pharmaceutical and medical subjects as well as of pharmacovigilance requirements. Experience in European regulatory CTA submissions. Comprehensive understanding of ICH/GCP and EU Clinical Trial Directive/ Regulation.Must be able to work with international project teams. Must be highly organized and to have the ability to prioritize job functions with attention to detail and within required timeframes.Flexibility and readiness of mind. Good communication skills. Ability to work in a team.Unbiased international view and inter-cultural competence. Ability to work in an independent, efficient and effective manner. Conscientious and able to work under time pressure.#IamBoehringerIngelheim because...
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