MSD Specialist Regulatory Affairs m/f/d 

Austria, Vienna 

483674954

Job Description

Operational component

• Ensuring Life-cycle maintenance of assigned, authorized products.

• Taking part in subsidiary product and launch teams to provide regulatory input and strategic advice.

• Participating in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

• Working in and with different databases.

Strategic component

• Providing guidance on pertinent EU and local regulations and guidelines. Collecting relevant public available regulatory information (regulatory intelligence) and informing relevant stakeholders.

• Maintaining a close relationship with internal (sub-regional, regional, global) and external regulatory contacts.

• Adequately supporting other functions to enable compliance in areas related to regulatory.

Qualifications

• Post-secondary education in scientific science or equivalent

• Excellent skills and knowledge of local and EU medicines legislation and regulatory procedures

• IT-skills with regard to word-processing, spreadsheets and database applications strongly required

• Good medical and scientific understanding and knowledge

• Solid experience in a Registration Department or equivalent dealing with most aspects of registration

• Ability to plan and prioritize regulatory tasks to meet company and local objectives

• Good interpersonal and managerial skills, capability of problem resolution, strategic thinking and the ability to work in a team environment

• Commitment, dedication to quality and the ability to handle multiple priorities simultaneously is a key condition

• Fluent in German and business proficient in English

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 48.600,- (based on fulltime employment) and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Current Contingent Workers apply

No Travel Required

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.