Senior Manager, CMC strategy - Homebased in UK, Poland, Spain or Germany
PRA Health Sciences
Req #: 121717
Type: United Kingdom
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Overview: Senior Manager, Regulatory Strategy (CMC strategy) - Homebased in UK, Poland, Spain or Germany As a Senior Manager, Regulatory Strategy (CMC strategy) you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs team at ICON. The Senior Manager, CMC Strategy is responsible for global CMC regulatory strategies and activities for a large Pharma portfolio through clinical development, market launch and product lifecycle management. The succesful candidate will provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally. Responsibilities: What you will be doing: * Defining, coordinating and implementing global CMC regulatory strategies for product specific development and life-cycle activities * Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets. * The role liaises directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters. * Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval. * Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives. * Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals. * Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders. * Identifies and recommends the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations. * Product registrations in global markets. * Provides proactive guidance and regulatory strategies to support product teams. * Interfaces with key functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs. * In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams. * In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully documented in the respective quality management system. * Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations. Qualifications: You are: * The role requires an extensive experience in global pharmaceutical/biotechnological drug development and proven knowledge of the global regulatory CMC environment. * Demonstrated experience in authoring and managing components of regulatory submissions * Good knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with FDA. Ablility to support regional and local regulatory affairs teams for Interactions with regional or local health authorities (e.g., EMA, PEI, AGES, PMDA, Health Canada, etc.). * Demonstrated ability to devleop and implement global CMC regulatory strategies, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities. * Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve development and commercial goals. * Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, drug development and/or expedited regulatory pathways. * A minimum of an undergraduate degree in a life-sciences discipline (or be a licensed healthcare professional). #LI-PH1 What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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