MSD Specialist Regulatory Affairs m/f/d 

Switzerland, Lucerne 

84425602

Job Description

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

• You will ensure timely preparation and submission of new local Marketing Authorization applications for assigned products as well as appropriate follow-up with the local authorities

• You will ensure timely preparation and maintenance including translations of local Product Circular, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to our Company’s and local standards

• You will participate in subsidiary product and launch teams to provide regulatory input and strategy advice

• You ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations

• You will develop and maintain positive relationship with key players in the regulatory environment and work with Business Development to boost business initiatives on local, regional and global level

• You will ensure efficient and consistent implementation and use of internal and external regulatory databases and systems in Switzerland

• You will participate in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied

• You will keep abreast of local and international laws; maintain a scientific knowledge and expertise for our Company’s therapeutic areas

QUALIFICATIONS:

• You hold a Degree in a Life Science Discipline or equivalent qualification

• You have a minimum of 2 years’ experience in a Registration Department including hands-on experience in dealing directly with Swissmedic. Alternatively, experience working within a regulatory agency or other related environment

• You have hands-on expertise in database application

• Your German language skills are at a native level and you are fluent in English. Additional French language skills are highly beneficial.

• You are a strong communicator and stakeholder manager; a diplomat with assertive skills in speaking with internal and external parties

• You possess very good organizational and planning skills and a proven ability to successfully handle conflicting deadlines

• You work client- focused and business-orientated and you have a sound appreciation of the interactions and relationships of the department with other internal groups

Current Contingent Workers apply

Not Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.