Regulatory Affairs Specialist
· Coordinate and support the regulatory submissions for the registration of
clinical, reimbursement and commercial release products within the Czech
Republic. The activities are carried out with coaching of the assigned Manager /
Regulatory Affairs contact.
· Prepare and coordinate regulatory submission requirements for projects
effectively to obtain timely product approvals within Czech Republic.
· Develop proficiency in the applicable regulatory requirements of the
Czech Republic.
· Interface with the appropriate Regulatory Representatives and
distributors on assigned projects/products activities.
· Performs independently complex administrative duties for accurate
databases. · Provide administrative support to the preparation of the Field
Corrective Action plans for Czech Republic, if applicable.
· Composition of tender offers and providing them with necessary
documentation.
· Provide support for vigilance process.
Požadavky:
University degree (preferable in pharma, medical or natural science)
+ years of experience in relevant regulatory environment
· Knowledge of country regulations
· Effective Interpersonal/Communication skills.
· Fluent English language in speaking and writing
· Trustworthy to safeguard confidential information
· Strong attitude to detail and quality in all reporting materials
· Ability to communicate effectively to all levels of organization and
customers
· Self-starter, with ability to work independently
· Office Automation systems
· Ability to travel
Nabídka:
Detaily:
Kraj: Praha
Vzdělání: VŠ
Aktualizováno dne: 24. 03. 2015
Kontakt
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