Regulatory Affairs Specialist

vor 2 Wochen

Munich, Deutschland OPTARES Gmbh & Co. KG Vollzeit

**[**5840**]**:
Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort.

To support our manufacturing team we are looking for a

**Regulatory Affairs Specialist (m/w/d)**

Your tasks
- Manage regulatory submission timelines and tracks documents through internal review and approval process and communicates changes or significant updates internally
- Manage regulatory vendor contracts and tracks budget and invoices
- Contribute to the planning and implementation of required regulatory submissions
- Responsible for the compliance and adherence to regulatory process for document filing and archiving
- Manage and oversight of external publishing vendor
- Maintain an awareness of regulatory activities across the companies projects
- Communicate key regulatory intelligence updates from EMA and FDA
- Support the VP RA in setting up processes and systems for RA activities

Your qualifications
- Degree in life science or healthcare discipline
- A minimum of 3 years experience in the pharmaceutical industry with at least 1 year in Regulatory Affairs
- Awareness of regulatory agency procedures preferably for products in the development phase
- Understanding of the key elements of the electronic Common Technical Document (eCTD) structure
- Basic understanding of processes and departments within a pharmaceutical company
- Strong project management skills and demonstrated ability to implement on planning activities
- Excellent interpersonal skills, self-motivation and sense of urgency to complete assignments on time
- Excellent communication skills in English with the ability to communicate at all levels
- Ability to work independently
- Familiar with MS Office, good working knowledge of planning and presentation tools
- Enjoys working in a fast paced environment

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