KGS - Life Sciences - AM - PUN - UK

Job Description

Support client engagements and define pharmaceutical or medical device regulatory service needs, project timelines, strategic goals and client expectations for delivery of regulatory services. Support regulatory affairs services with an emphasis on regulatory strategy and the preparation, review and submission of documents to regulatory authorities globally. Provide life science regulatory advice to cross-functional teams on regulatory requirements to support regulatory submissions to authorities in different global jurisdictions. Support teams responsible for the technical review, authoring or assembly of Clinical, Pre-Clinical or CMC dossiers, for example preparation and maintenance of IND, CTA, EU IMPD, NDA, BLA, MAAs or scientific advice procedures with global regulatory authorities. Help to research strategy for clinical development and product development plans for pharmaceutical products or medical devices and product launch considerations with Managers. Able to effectively communicate with clients and project teams through correspondence, regulatory status reports as defined and agreed with the client. Understands the global regulatory environment and advises clients of regulatory changes in the future within Life Sciences and how these changes should be managed. Maintains current knowledge of EU, FDA and global regulations as necessary depending on client requests. Advise clients on the impact of the changing pharmaceutical regulatory landscape on their business models and support them through change. Provide subject-matter expertise on engagements run by others. Develop and maintain strong relationships with clients and build an external network Develop and maintain strong relationships with KPMG colleagues and build an internal network Support mentoring, coaching and development of colleagues. Support with business development opportunities for the Life Science Regulatory Services Team and wider business, which might include building propositions and taking these to market as well as identifying opportunities for on-sell from existing client engagements. Support research, insight development and knowledge management. Ensure the delivery of all client work and internal projects to a high standard., *Roles and responsibilities Support client engagements and define pharmaceutical or medical device regulatory service needs, project timelines, strategic goals and client expectations for delivery of regulatory services. Support regulatory affairs services with an emphasis on regulatory strategy and the preparation, review and submission of documents to regulatory authorities globally. Provide life science regulatory advice to cross-functional teams on regulatory requirements to support regulatory submissions to authorities in different global jurisdictions. Support teams responsible for the technical review, authoring or assembly of Clinical, Pre-Clinical or CMC dossiers, for example preparation and maintenance of IND, CTA, EU IMPD, NDA, BLA, MAAs or scientific advice procedures with global regulatory authorities. Help to research strategy for clinical development and product development plans for pharmaceutical products or medical devices and product launch considerations with Managers. Able to effectively communicate with clients and project teams through correspondence, regulatory status reports as defined and agreed with the client. Understands the global regulatory environment and advises clients of regulatory changes in the future within Life Sciences and how these changes should be managed. Maintains current knowledge of EU, FDA and global regulations as necessary depending on client requests. Advise clients on the impact of the changing pharmaceutical regulatory landscape on their business models and support them through change. Provide subject-matter expertise on engagements run by others. Develop and maintain strong relationships with clients and build an external network Develop and maintain strong relationships with KPMG colleagues and build an internal network Support mentoring, coaching and development of colleagues. Support with business development opportunities for the Life Science Regulatory Services Team and wider business, which might include building propositions and taking these to market as well as identifying opportunities for on-sell from existing client engagements. Support research, insight development and knowledge management. Ensure the delivery of all client work and internal projects to a high standard.

Keyskills :
project teamsclinical developmentproduct developmentproduct launchbusiness developmentmedical deviceslife sciences