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Orion Group
,
London, Greater London
Regulatory Affairs Associate
Overview
Orion Group Life Sciences have an exciting opportunity for a Regulatory Affairs Associate for our Multinational Pharmaceutical client based in the Middlesex area on an initial 12-month contract. Job Purpose The Regulatory Professional under the direction of a Regional Regulatory Lead will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision. Main Responsibilities of the role Collect and / or create country specific documents for regulatory filings worldwide Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead Ensure compliance via timely submissions to regulatory agencies Coordinate collection of functional documents in support of regulatory applications As appropriate support execution of regulatory strategy Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance Train and supervise junior staff Desired Experience and Background of the successful candidate Understanding of drug development process; knowledge and understanding of CMC requirements, especially country specific documents for international filings Familiarity with Document Management Systems Strong communication skills - oral and written Ability to multi-task in a fast paced environment Organizational skills pharmaceutical medical multinational product drug regulatoryaffairs CMC CTA MA For more information on this role, call Kate O' Sullivan on 44 (0) or email for a completely confidential chat about this role and other opportunities using the reference number: 930555 Our role in supporting diversity and inclusion As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.