Title:Regulatory Affairs Specialist
Time Status: Full-time
Location: Budapest, HU
Salary: Competitive
Opportunity to travel to the US
Job Description
Vanessa Research Magyarország Kft. is a subsidiary of a Connecticut based biomedical company that discovers, develops and commercializes innovative medical products in areas of unmet medical needs.
We are seeking a Regulatory Affairs Specialist with experience in new drug approval process as applicable to the clinical trial procedure and marketing authorization.
Familiarity with GMP certification procedure for contract manufacturing is essential.
The candidate will prepare, coordinate, review and submit domestic and international regulatory applications, collect all the necessary documents, approvals; effectively plan and manage regulatory variations. The ideal candidate must be familiar with European and US regulatory systems. The Regulatory Affairs Specialist will work closely with the Research & Development and Manufacturing division.
The position will provide an opportunity to contribute to the strategic directions of the company and make impact by supporting our ultimate goal of ‘giving hope where none existed.’
Duties and Responsibilities:
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Prepare, coordinate, review and submit domestic and international regulatory applications
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Maintain relationships with local and foreign authorities and act as a regulatory contact
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Assisting in establishing GMP facility for Investigational New Drug certified manufacturing
- Assist in defining drug approval pathway
Qualifications
Basic Qualifications
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Degree in Medicine, Life Sciences, Pharma and/or Law
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3-5 years of experience in relevant position
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Proven record of successful regulatory applications
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Proficiency with European and US regulatory systems
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Experience with GMP certification
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Excellent time and project management skills
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Effective communication and writing skills
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Ability to work effectively in a diverse work environment
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Proficient with MS Office tools
What we offer
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Competitive compensation with bonus performance incentives
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Working with a global, diverse team of dedicated, highly-skilled professionals
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Opportunity to join a rapidly growing business at an early stage, where each employee can make a difference and directly contribute to the success of the company
If interested, please send your English CV and cover letter to marton.kubinyi@vanessaresearch.com
About Vanessa Research:
Vanessa Research was founded on the desire to build a 21st century, sustainable, innovative, entrepreneurial organization by bringing together a collection of diverse scientists, engineers, business professionals, and academics to create solutions in medicine. The company has etched its niche in developing innovative products by commercializing complex ideas with simple solutions. This is done by creating a fun respectful teamwork environment conducive to open unrestrained dialog and invention.