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Attendeer FMF hierop
Senior Regulatory Affairs Manager
Handling CMC dossiers for gene and cell therapy
Het bedrijf / The company
Our client is a multinational pharmaceutical company with EMEA headquarters based in London and affiliates throughout Europe. The client is engaged in Research and Development (R&D), Manufacturing and Sales and Marketing. The EMEA region is important and growing because they have key strengths in the various therapy areas. In the organisation they believe that nurturing a good relationship with employees delivers good business results. They are aiming to become recognized as an Employer of Choice. This means ensuring they are a highly effective organization, that applies best-in-class people management, creating a positive working environment and having an inspirational company culture. Because of the growth in the EMEA region they are looking for a motivated and specialized Regulatory Affairs Manager in CMC for Biological Products.
De functie / The role
A suitable candidate will be responsible for developing submission plans for assigned projects and provides input for RA strategy. You identify and collect data required for registration packages, often including initial IND submissions for later stage development products. You will take responsibility for the development and implementation of Regulatory processes within the department. As a Regulatory Manager you are responsible for independently managing complex technical documents. You prepare, review, and submit to global Regulatory agencies. Therefore you prepare INDs & NDAs, amendments, and supplements, as well as responses to questions from Regulatory agencies. Also, you prepare and/or review summary tables of data from research and manufacturing reports, without direct supervision. You develop strategies for new assignments while having less-defined Regulatory frameworks. You also execute Regulatory strategies with management guidance. Regularly you interact with senior management within areas of responsibility. You establish reports with FDA review staff and interacts regularly including negotiations in new areas. You also participate in FDA meetings and you will manage the planning process. Furthermore, you advise global and local teams on Regulatory requirements, and interpret and ensure compliance with applicable FDA/ICH regulations. Finally, you interact with international marketing staff to define the most appropriate Regulatory strategies to utilize in international product registrations, both in original submissions and to support existing registrations.
Het profiel / Your profile
• At least a Bachelor’s degree in a scientific or related discipline.
• At least 7 years of industry experience combined with 4 years in RA.
• Expert level of scientific knowledge in chemistry, general biological/physical science, and ability to apply that knowledge to Regulatory issues and product development.
• Recognized as skilled in an aspect of pharmaceutical drug development, with RA skills.
• Full knowledge of FDA and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
• Strong organizational skills with the ability to manage large projects and provide Regulatory guidance/training to others in the department.
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
• Excellent written and oral communication skills, with writing ability to meet Regulatory.
• Solid experience in gene or cell therapy.
Het aanbod / The offer
• A challenging and diversified job.
• Working in a multicultural and international environment.
• Working partly remotely (during COVID-19, completely).
• A permanent position for 40 hours a week.
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to WL/20-071-FMF, to Sandra van Putten: email@example.com.
For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.
Tenslotte ..... / Finally ....
An individual assessment may be part of the selection procedure.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.