Job Opening:
Support in Regulatory Affairs
Website Onesource Consulting
Job Description
Under supervision of the Regulatory Affairs Country Lead, the incumbent is responsible for providing regulatory administrative support and coordination for the department with maintenance of tracking systems and databases, minor translations, preparing submissions, renewals and PSURs and maintenance of local files as well as minor translations and artwork management.
• Under supervision of Regulatory Affairs Country Lead the incumbent contributes in other regulatory tasks, as required.
• By discretion of Regulatory Affairs Management and due to organization and work load, all listed activities need not to be performed.
What you’ll do
Administrative office routines:
• Assists in compilation and submission of regulatory documents to the local regulatory authorities and – as applicable – to the European Medicines Agency (EMA) related to new applications, variations, renewals, PSURs etc.
• The above mentioned tasks are performed under supervision of Director/(Sr) Manager Regulatory Affairs.
Compliance:
• Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs.
• Ensures that regulatory databases and systems are kept updated and complete.
• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
• Manages the planning and submission activities for PSURs, in cooperation with regional and global teams.
Editing and labeling:
• In connection with submission of MA applications, variations, renewals and PSURs etc assists in preparation, translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and performs quality assurance including linguistic check of these documents.
• Co-ordinate Electronic Medicines Compendium submissions, approvals and record keeping.
• The above mentioned tasks are performed under supervision of Director/(Sr) Manager Regulatory Affairs and relevant persons in medical and marketing departments as well as Regulatory Affairs International, Worldwide Product Labeling, Regulatory Affairs Europe, and MMD Europe.
Art-work development:
• Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.
• Packaging Material is developed in cooperation with the MMD, RAE coordinators, the Product Manager, and (Sr) Manager Regulatory Affairs.
• The incumbent proof reads packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
• The above mentioned tasks are performed under supervision of Director/(Sr) Manager Regulatory Affairs.
Profile
The incumbent must have a post-secondary education in scientific science or equivalent.
The incumbent must demonstrate basic medical and scientific understanding and knowledge.
The incumbent should demonstrate basic skills and knowledge of local and EU medicines legislation and regulatory procedures.
The incumbent must have the ability to plan and prioritize regulatory tasks to meet Merck and local objectives.
The incumbent must demonstrate good interpersonal and managerial skills, capability of problem resolution 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.
The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database applications, and internet.
For seniority, a minimum of 2 years’ experience in a Registration Department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager. A sound appreciation of the interactions and relationships of the dept with other groups internally is expected.
Required Skills
2 years local RA experience is required
Pharmacist background is a must
Language: Dutch /French/English + (optional) German reading
What’s in it for you?
This is a position for min 32 hours (4 days a week fixed – max 1 day Home working )