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Regulatory Affairs Associate (m/f/d) (DE)
[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 team we are looking for a Regulatory Affairs Associate (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 For further questions, please contact Mr. Tilman Grumbd at +49 441 21879-34 or via e-mail at tilman.grumbd@optares.de
- 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
Tilman Grumbd