Regulatory Affairs Consultant (Veterinary Medicinal products)

Parexel International Corporation

Romania - Any Region - Home Based

We are currently looking for a Regulatory Affairs Sr. Associate/Consultant (Veterinary vaccines) who will have the following responsibilities: Regulatory assessment of change control requests (mainly CMC) in change control system and under consideration of all relevant SOPs and with respect to regulatory compliance (e.g. variations). Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects Initiation and co-ordination of quality (CMC) documents preparation for required regulatory activities to ensure regulatory requirements. Review and assessment of the above-mentioned quality documents under regulatory aspects (regulatory compliance, requirements of European competent authorities for veterinary medicine). Compilation of submission documentation (data packages/dossiers) for handover to the publishing team. Review and assessment of the submission documentation following publishing (and before submission to competent authorities) regarding completeness as per template and accuracy. Response to deficiency letters and authority request in due form (template) and time

QualificationsThe deal candidate will possess: BSc Degree in veterinary medicine or advanced degreeAt least 3-5 years of pharma/biopharmaceutical regulatory experience Good understanding of CMC lifecycle maintenance activities across EU (and US - it would be a plus) Change Control assessment experience (application of relevant regulatory guidance to proposed change) CMC Submission experience of Simple (Type I) and complex variations (Type II) to EU markets in the CP, MRP and NP procedures. Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME Able to adhere to internal and HA timelines Strong problem solving and diplomacy skills Exposure to regulatory requirements for biologic product development is highly desired Good project management skills English advanced level

2021-11-25 00:05:26

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