​
Director of Regulatory Affairs
Location Berlin
Salary Negotiable
Discipline Medical Devices
​
Responsibilities:
Manages preparation CMC related documents, CMC regulatory data for assigned Medical Device role out and LCM activities
Execute the CMC RA Strategy for assigned products
As Business partner to the Medical Device CMC team manages the CMC regulatory activities and CMC submission strategy of Medical Device dossiers and submissions that best serve the client's needs and ensure compliance with the regulatory systems
Translate agency questions in regulatory CMC positioning, to create a comprehensive story line and CMC responses
Act as Regulatory Affairs CMC lead for roll out activities and LCM
Interacts with the Regional Regulatory group and country contacts in relation to submission planning, timelines for responses and informs them about upcoming changes to the product that lead to variations
Interact with the CMC teams and site representatives for preparation of response to questions and specific CMC documentation requests
Other Tasks:
Manage, prepare and finalize Quality regulatory documents which form the basis of worldwide submissions such as: initial marketing authorization applications
Provide RA CMC expertise on submission strategy for assigned projects
Manage the completion of the relevant Quality documentation to allow timely submissions for the assigned products/countries
Manage, plan and timely finalize responses to Quality issues from Authorities
May prepare briefing books and provide support at Regulatory agencies meetings on quality issues
Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities
assess manufacturing Change Control Proposal (CCP) and justify the implementation in the major (and relevant) countries
Carry out regulatory review of CCPs, study protocols and reports, as well as other relevant regulatory documents intended for the product documentation platform or to local submission. Link with authors and data generating functions (as applicable) or data providers
Keep up-to-date with the current regulatory environment and Quality area, coordinate timely implementation of any changes or new relevant laws or guidance; provide comments on new laws on behalf of client through the appropriate procedure, as applicable
Ensure regulatory filing systems are maintained and up to date
Lead CMC Regulatory task forces on assigned projects
Serve as an interface between company functions as appropriate
Carry out any other tasks as required by the function to achieve its mission and objectives
Requirements
Life science Degree or technical degree
At least 5 years Regulatory Affairs CMC experience
Experience in BLA/MAA or variations
Experience in biological product development
Experience in submission and approval of tech transfer to new sites
Other:
Native German and Fluent English
Excellent written and spoken communication skills
Excellent interpersonal skills
Good organisational and planning skills
Attention to details
Ability to work in teams
​