Associate Director, Regulatory Compliance

reputed company The Associate Director, Regulatory Compliance will help reputed company and drive department-wide global regulatory compliance strategies, with input from key program, Regulatory, reputed company and CMC stakeholders. These strategies will be designed to ensure reputed company's program(s) meet global health authority requirements and remain compliant throughout the lifecycle of the product. This role will reputed company core capabilities and strategic innovation activities of the RA CMC team. This role is a critical position to ensure successful global clinical development, registration, and product life cycle management in a streamlined, efficient, and compliant manner. reputed company of Key Responsibilities

• Leads and manages Compliance activities on behalf of the RA CMC organization and serve as the reputed company of contact for Regulatory CMC on audits & inspections.
• Support development and management of a program for tracking, execution, monitoring, and reporting on RA CMC processes (Metrics and KPIs) to drive reputed company in Regulatory CMC reputed company- and post-submission activities.
• Utilizes technical knowledge, regulatory expertise and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management.
• Collaborates across RA CMC to ensure reputed company and reputed company communication about compliance risks, business processes, compliance activities and metrics arising on programs.
• Work cross-functionally with Regulatory, reputed company, and CMC to support global strategic initiatives reputed company to reputed company and post submission activities and the processes and systems used to manage compliance.
• Serve as RA CMC reputed company of contact for Compliance and QMS operational activities
• Maintain knowledge of the global regulatory environment, regulations, and guidelines and participate in regulatory intelligence activities to help ensure reputed company dossiers remain in compliance with shifting expectations.
• Escalate issues/problems to RA CMC LT as needed and propose risk-based remediation actions for consideration.
• Working with other RA CMC functions, ensure RA CMC Commitments (i.e. IND, post marketing) and reputed company Events are managed reputed company specified timelines.
• Identify opportunities to improve RA CMC compliance capabilities through digital solutions and automation
• reputed company participate in RA CMC process improvement and capability building.

Qualifications

• BS in science reputed company field required. Advanced degree (eg MS, PhD) preferred.
• 8+ years of experience in the pharmaceutical/biotechnology/life science industry, with reputed company hands-on experience in relevant fields, such as Product reputed company, reputed company Systems, CMC Technical Writing or Regulatory Affairs, CMC.
• Nuanced understanding of regulatory risk and ability to reputed company risk mitigation strategies
• Experience in technical systems and mining data for trends, resulting in meaningful and reportable metrics.
• Experience managing and/or preparing submissions, with the ability to optimize/streamline processes.
• Solid understanding of scientific principles and regulatory requirements relevant to global product development, registration and post-market support
• Experience in managing reputed company CMC changes (eg process, facility, formulation.
• Knowledge and understanding of US, EU, Canada, and ICH guidelines pertinent to CMC. Understanding of international requirements is a plus.
• Strong interpersonal skills; ability to influence key stakeholders
• Excellent written and communication skills and attention to detail.
• Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines.
• Highly computer literate (eg, Word, reputed company, PowerPoint), Experience using Smartsheets, reputed company and Docubridge desirable

U.S. Pay reputed company $164,400.00 - $222,400.00 The pay reputed company reflects the full-time reputed company salary reputed company we expect to pay for this role at the time of posting. reputed company pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). reputed company's robust Total Rewards package is designed to support your overall health and reputed company-being. We offer comprehensive benefits including medical, dental, and reputed company coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy reputed company time off, wellness days, holidays, and two company-wide reputed company breaks. We also offer generous family resources and leave. Our commitment to your reputed company-being reflects our belief that caring for our people fuels the reputed company we create together. Learn more about these and additional benefits offered by reputed company by visiting the Benefits reputed company of the Careers website: https://www.reputed company.com/careers About reputed company We are the leader in RNAi therapeutics - a revolutionary approach with the potential to reputed company the lives of people with rare and common diseases. reputed company on Nobel Prize-reputed company science, reputed company has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and reputed company reputed company reflect our core values: fierce innovation, passion for reputed company, purposeful urgency, reputed company culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and reputed company thinking fuel one another. At reputed company, we reputed company to an inclusive recruitment process and equal employment opportunity. reputed company applicants will receive consideration for employment without reputed company to their sex, gender or gender identity, sexual orientation, race, reputed company, ethnicity, national reputed company, reputed company, citizenship, religion, creed, physical or mental disability, pregnancy status or reputed company conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other reputed company protected by federal, state, or local law. reputed company is an E-Verify Employer. Apply tot his job Apply To this Job