Reference Number: JO-2006-451270
Regulatory Affairs Manager – CMC
Job Type: Permanent
Location: Dublin City Centre
Regulatory Affairs CMC Manager
Location: Dublin – Offering extensive home working.
Salary: Up to 80,000 per annum + benefits.
Job reference: JO-2004-449510
Regulatory Professionals are collaborating with an expanding pharmaceutical organisation specialized in rare diseases and orphan drugs. In this position you will plan, author and manage the assembly and timely submission of CMC activities across both developing and market products.
– Developing and implementing strategies for the earliest possible approvals of regulatory submissions.
– CMC regulatory strategies
– Providing expertise on CMC regulatory matters
– Maintaining current regulatory knowledge and awareness of new scientific or manufacturing technology and advise management of significant developments
– Must have a relevant life sciences degree
– Experience and knowledge in preparation of CMC sections of IMPD, IND, MAA, NDA
– Working knowledge of EMA, FDA and ICH regulatory guidance and regulations.
– 5+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
– Experience with biological products would be advantageous.
If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or Charlie.Harris@Regulatoryprofessionals.com.
If you are not currently looking but know someone who would be good for this role then get in touch.
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