Regulatory Affairs Manager - Clinical (m/f/x)
|Job Title:||Regulatory Affairs Manager - Clinical (m/f/x)|
|Contact Name:||Sebastian Gotzler|
|Job Published:||December 10, 2020 09:01|
Regulatory Affairs Manager - Clinical (m/f/x) | Munich | Pharma
Your ambition is to get to know the radiotheranostics industry a little better? You are an expert in Regulatory Affairs for Clinical Trials and have a strong background in developing regulatory strategies and preparing regulatory documents?
If you are interested in experiencing this at a very well-positioned medium-sized and internationally operating company, then you have come to the right place!
What will your activities as Regulatory Affairs Manager - Clinical involve?
- Responsible for managing regulatory Clinical Trial Applications submission activities or other regulatory procedures for complex theragnostic radiopharmaceutical products, including proactive identification of regulatory risks and mitigation strategies.
- Accountable for the implementation of the global CTA submission strategy, as well as the quality and extensiveness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
- Collaborate with external CROs and internal clinical development teams in the execution of clinical regulatory activities.
- Write and/or review of regulatory documents required for filing of IND/CTAs, including but not limited to clinical study protocols, informed consent forms, investigator's brochures, responses to the Health Authority questions, case report forms, and other relevant documents.
- Prepare and/or review briefing documents for Health Authority meetings.
- Supports development of Target Product Profile for assigned development projects.
- Monitor changes in the regulatory environments and advise on company adaptive responses.
What requirements should you bring along?
- Life science degree.
- Proficiency in English (written and oral).
- Ability to work in a hierarchically flat, matrix environment.
- Minimum 5 years of regulatory experience, ideally with products in Phase I - Phase III clinical development. Experience with diagnostic radiopharmaceuticals will be an asset.
- Preparation of CTAIND submissions to FDA and EU regulatory authorities.
- Regulatory writing.
- Good management, interpersonal, communication, negotiation and problem solving skills.
Information about our customer:
Our client is a medium sized company dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Their portfolio and growing pipeline of targeted treatments in various stages of clinical development addresses a wide range of cancers.
Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!
I look forward to your application!
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