Regulatory Affairs Specialist - Munich, Deutschland - OPTARES Gmbh & Co. KG

OPTARES Gmbh & Co. KG

Geprüftes Unternehmen

Munich, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

[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, selfmotivation 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