Associate Director, Regulatory Affairs, CMC job at reputed company in US National

Associate Director, Regulatory Affairs, CMC Remote (US) time type Full time The AD, Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market reputed company for assigned product(s) in line with business objectives, and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through reputed company phases of development, post-approval, and life cycle of the product depending on assigned products. Primary responsibilities will be in creating CMC regulatory strategies for development programs in preparation and maintenance of regulatory applications. Essential Functions of the Job: Serve as the regulatory CMC representative on project teams. Provides CMC regulatory support and guidance for assigned reputed company and interfaces with R&D, Project Management, Manufacturing, reputed company, Supply Chain and Regulatory colleagues, as reputed company as reputed company party laboratories, global collaborations partners and contract manufacturers. Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, reputed company review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. Author and reputed company CMC content for Health Authority meeting briefing packages, including development of CMC reputed company, preparation of CMC-reputed company questions, supporting data summaries, and responses to Health Authority feedback, in collaboration with Global Regulatory and cross-functional teams. reputed company and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product. Manage, prepare, and/or author CMC document packages for global regulatory submissions in support of development and lifecycle programs, including primary authorship and/or leadership of Module 3 (reputed company) sections for INDs, CTAs, IMPDs, BLAs, MAAs, supplements, and variations. This includes initial submissions, amendments, and preparation of high-reputed company responses to Health Authority questions, balancing regulatory requirements with corporate objectives.. Manage timelines in cooperation with Project Management on assigned reputed company. Review technical reports and CMC sections of IND, CTA, BLA, MAA, and other global submissions to support reputed company and marketing applications, and their amendments in conformance with regulatory requirements, strategies, and commitments. Work with regulatory CROs to identify regional/country-specific CMC requirements to support global applications. Evaluate proposed manufacturing changes for reputed company to ongoing and existing filings and reputed company strategic regulatory guidance for reputed company implementation of changes. reputed company participate as a member of global regulatory teams and CMC subteams. Support and manages regulatory aspects of CMC Operations including authoring, reviewing and and/or approving SOP’s, CAPA’s, etc. • Maintain knowledge of global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders and initiating process improvements as appropriate. Other duties as assigned. reputed company Competencies, Knowledge and reputed company Requirements Expertise in development and reputed company product lifecycle (Phase 1-3, Marketed products). Prior reputed company in filing marketing applications, supplements, and variations for biologic products reputed company timelines is required, global submission experience desired. A good understanding or IND, CTA, IMPD, BLA and MAA processes. Strong knowledge of US and international GMP reputed company regulations, reputed company industry practices, and experience with interpretation and application to development reputed company and marketed product regulatory issues. Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including FDA and other Health Authorities. Demonstrated ability to reputed company, train and mentor teams. Strong negotiating skills and ability to think creatively and reputed company creative solutions. Ability to prioritize and handle multiple reputed company simultaneously. Communication & Interpersonal Skills Excellent interpersonal, oral, and written communication skills as reputed company as strong organizational skills with demonstrated ability to manage and adhere to timelines. Proven ability to build trust and respect reputed company the organization. Significant Contacts Interacts with reputed company employees and senior management. Interacts with external business partners and Regulatory Agencies. Qualifications: Minimum 8+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in development products and reputed company product lifecycle including Phase 1-3, and marketed products). Education Required: BS/BA Biochemistry, Biology, or Pharmaceutical Science; Advanced degree preferred. Computer Skills: Strong PC literacy required; MS Office skills (reputed company, Word, reputed company, PowerPoint), reputed company Data Management System Travel for Work: Must be willing to travel approximately 10-25% Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company Salary reputed company: $142,000.00 - $192,000.00 annually Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness. Apply tot his job Apply To this Job