Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Director - Munich, Bayern - Innovaderm Research
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Regulatory Affairs Director
vor 2 Monaten
About the Role:
We are seeking an experienced Associate Director, Regulatory Affairs to join our team at Innovaderm Research. As a key member of our regulatory affairs group, you will be responsible for managing and overseeing the services provided by the Regulatory Affairs team in assigned regions.
Key Responsibilities:
- Provide leadership on regulatory activities that lead to global start-up of clinical trials
- Plan and assign work, oversee the performance of direct reports, and perform annual reviews
- Address employee relation issues and escalate concerns as necessary
- Oversee the preparation and submission of Clinical Trial Applications and IRB/IEC packages
- Ensure compliance with SOPs, industry standards, regulations, and study-specific requirements
- Manage performance, establish clear objectives, and conduct formal performance reviews
- Develop direct reports and ensure adequate resources to sustain activities of the group
- Serve as a subject matter expert in regulatory affairs and assist with development of submission strategies
- Communicate with project teams, sponsors, and regulatory authorities as necessary
Requirements:
- At least 8 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, and/or CRO industry
- 3 years of experience in a management role
- Experience preparing, reviewing, and submitting Clinical Trial Applications and IRB/IEC packages
- Solid knowledge of review and approval processes of applicable regulatory Health Authorities
- Ability to assess impact of evolving information and provide guidance
- Excellent knowledge of Microsoft Office suite and fluent in English
About Innovaderm Research:
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We offer a stimulating work environment and attractive advancement opportunities. Our values are collaboration, innovation, reliability, and responsiveness.
What We Offer:
- A competitive salary and benefits package
- Opportunities for professional growth and development
- A dynamic and collaborative work environment
- The chance to work on exciting projects and contribute to the success of our clients
How to Apply:
If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].
