Beschreibung
For our customer in Bern we are looking for a project ASAP for a
Senior Regulatory Affairs Specialist
This role demands the candidate to draw on relevant expertise and information from both internal and external sources, and make a major contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions.
Responsibilities:
Responsible for designated product projects working within overall policies and strategies Preparing regulatory documentation for submissions such as clinical trial applications, marketing authorization applications, variations, renewals etc. in a timely and efficient manner Responsible for dossier establishment, time-plan coordination and regulatory submission plan and coordination of the activities between relevant functions (development group, project team, clinical, etc.) Revising the CMC documentation and ensure good quality of the regulatory relevant documentation Preparing the concept for the final regulatory strategy with respect to WHO and is responsible for the harmonization of WHO and NRA strategies (issues, submissions, meeting etc.) Responsible for the good quality and conformity to regulatory requirements of the submissions Preparing position papers and the regulatory sections of project plans for review and approval by supervisor Consulting on regulatory strategy, plans and manufacturing change control proposals Authorizing and drafting original texts (eg summaries, linking texts, labels and leaflets, letters). Reviewing and commenting on documents from other departments. Representing RA in project teams Being an interface between R&D, marketing, quality, production, company subsidiaries and partner companies Non- Technical Requirements:
Must be able to work on multiple simultaneous tasks with limited supervision Quick learner, motivated self-starter Excellent customer service, interpersonal, communication and team collaboration skills Able to follow change management for internal guidelines Language proficiencies: English spoken and written; German is nice to have Are you interested in this position? Then we are looking forward to receiving your application.
