Manager (m/w) Global Regulatory Affairs Projects in Darmstadt
On behalf of pharmaceutical company we are looking for candidates to support the regulator affair processes. The successful candidate should have experience and natural science background. The position is based in Darmstadt and start date is 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).
- Support Mature Product Leads in the Global Regulatory Mature Products group in ensuring strategies and submissions are implemented with the utmost quality
- Complying with both internal and external processes and requirements
- Manage the 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 of a TA Head or Regulatory Strategist)
- Contribute to development and evaluation of regulatory strategies for projects (under supervision of the Regulatory Strategist.
- 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. Support the Mature
Please forward your application to tom.sander or apply online https://www.recruiting-randstad.de/generator.php?id=545.
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