On behalf of our client we are looking for a pharmaceutical experienced candidate to support our Regulatory Affairs team in Darmstadt asap.
You assist the Global Regulatory Lead and/or the Regional Lead in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical trials, marketing applications or other related regulatory submissions (Orphan designation and annual report, pediatric plans, DSUR, PBRER).
- ensuring strategies and submissions are implemented with the utmost quality while complying with both internal and external processes and requirements.
- regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones.
- Manage regulatory agency interactions, document preparation, co‐ordination rehearsals and minutes (under supervision).
- Contribute to development and evaluation of regulatory strategies for projects (under supervision )
- Review and provide regulatory comments to quality‐, safety‐ and efficacy or labeling related documents (e.g. protocols, reports) to be included in a regulatory submission (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities, PIP/PSP, ODD, DSUR...).
- Contribute to the development of risk assessment pertaining to the quality‐, safety‐ and efficacy documentation/data of investigational medicinal products related applications.
· Degree in Life Science or related discipline, higher degree preferable (Pharm.D., MSc, PhD, MBA)
· Minimum of 5 years’ industry experience of which at least 3 years’ regulatory experience
· Solid knowledge of European regulatory procedures and requirements
· Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
· Experience with regulatory agency interactions and preparation of documentation to support interactions
· Experience in IND / CTA requirements
· Knowledge of international regulatory affairs
· Experience with maintenance of regulatory authorizations in at least one region
· Experience with supporting a project with development activities in at least one region
· Excellent spoken and written English
Please forward your CV to firstname.lastname@example.org or https://www.recruiting-randstad.de/generator.php?id=608. If you have any further questions please do not hesitate to contact Tom Sander.
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T +49 621 1206942
Type of employment: Full Time