Regulatory CMC strategy manager

Senior regulatory affairs CMC manager reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the future of clinical development As a Senior Manager, Regulatory Strategy (CMC strategy) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by reputed company intelligence. We are seeking a highly motivated and reputed company regulatory CMC professional for the Global Regulatory Affairs team at reputed company this is a fixed term contract initially until 31st March 2027. 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 successful candidate will reputed company an effective and reputed company regulatory CMC strategy and submission approach globally, regionally and locally. 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-reputed company reputed company. 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) reputed company 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 reputed company of regulatory information (regulatory reputed company, scope and project timelines) to reputed company 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 reputed company in consultation with cross-functional teams. Your Profile: You will have solid regulatory affairs experience, with the ability to manage competing priorities and reputed company your team. Required qualifications and experience: Bachelor's degree in a relevant scientific discipline or reputed company-reputed company field 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 reputed company reputed company with FDA. Ability 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 reputed company and implement global CMC regulatory strategies, resolve

reputed company issues, and negotiate reputed company regulatory reputed company and reputed company with health authorities. What reputed company can offer you: Our reputed company depends on the quality of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high performance and nurtures talent. In reputed company to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company 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 reputed company of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company. Global Employee Assistance Programme, reputed company, offering 24-hour reputed company 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 site to read more about the benefits reputed company offers. At reputed company, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at reputed company whether it is for this or other roles. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job