Description
We are looking for a
DRA Project Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Basel-Country
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Acquire and maintain an overview of relevant regulatory requirements and guidelines
- Assume EU regulatory responsibility for individual tasks on assigned projects, such as the creation and finalization of key regulatory documents (IMPD) as well as ensuring submission to HA (EU) scientific advice packages, Module 1 documents for EU and support for global submissions (MAA, etc.), variations
- Represent DRA (together with the Global DRA-PL) in lifecycle-, CT- and other project related meetings and other governance related meetings
- Collaborate closely with the Global US-based DRA partner for regulatory considerations on assigned projects
- Support Global DRA-PL on creation and finalization of strategic DRA documents such as Regulatory Functional Plan
Your qualifications
- Bachelor’s degree, in life sciences, medicine, pharmacy or equivalent
- Basic knowledge of regulatory legislation and guidelines
- Basic understanding of the regulatory aspects at various stages of development, from EIM to post-approval activities
- Familiarity with clinical trial methodology and statistics
- Capable of working independently as well as effective team player
- Ability to work within tight timelines with very good project management skills
- Excellent communication, interpersonal, negotiation and problem solving skills
- Accuracy, reliability and diligence
- Excellent spoken and written English
Skills:
- Regulatory affairs assistant
- Project manager