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Orion Group
,
Cambridge, Cambridgeshire
Regulatory Affairs Associate
Overview
Orion Group Life Sciences are looking for a Regulatory Affairs Associate for our Multinational Pharmaceutical client based in the Cambridgeshire area on an initial 12-month contract with the potential to extend. Job Purpose The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Main Responsibilities of the role Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications Review regional component of the Global Regulatory Plan and provide input to operational deliverables Ensure compliance via timely submissions to regulatory agencies Support RRL in review of promotional materials for commercial activities (ex-US) Collaborate with CRO's / partners to support site initiation Coordinate collection of functional documents in support of regulatory applications As appropriate participate in GRT to support execution of regulatory strategy Coordinate QC of regulatory documentation (e.g. briefing packages) Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) Prepare regulatory packages and cross-reference letters to support investigator initiated studies Approve drug shipment for client and Investigator Initiated Studies Complete regulatory forms to support agency communications (E.G. EudraCT,) Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams Support process improvement initiatives, standards development, and metrics Assist in template development and maintenance Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams Actively support regulatory compliance Support the development and execution of GRT goals Desired Experience and Background of the successful candidate Understanding of drug development process Strong communication skills - oral and written Organizational skills pharmaceutical pharma multinational product regulatoryaffairs drugdevelopment 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: 930161 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.