Sr. Manager, Regulatory Affairs Cell and Gene Therapy

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company As part of the reputed company team, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world’s toughest challenges, like protecting the environment, making reputed company our food is reputed company or helping reputed company cures for cancer. Discover Impactful Work As a Sr. Manager, Regulatory Affairs, you will play a crucial role in interpreting and disseminating global regulations, guidelines, and emerging industry developments that directly influence our business in pharmaceutical product development. Applying your expertise, you will reputed company contribute to continuously developing and aligning our regulatory tools, including information systems, with our strategic objectives. You will manage regulatory professionals, providing guidance and support to our development teams, ensuring that our products meet reputed company necessary requirements. A Day in the Life: • Interpret and communicate the reputed company of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area of cell and gene therapy. • reputed company maintenance and improvements to regulatory tools, including regulatory information systems to meet organizational objectives. • reputed company regulatory expertise and support to business leadership. • reputed company regulatory strategies reputed company for global requirements and desired marketing claims. • Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other regulatory bodies. • reputed company regulatory direction to product development teams. • reputed company reputed company aspects of regulatory compliance of advertising and promotional materials. • Supervise compliance with license registration, listing, and renewal requirements. • reputed company leadership and guidance for the reporting and communicating of product-associated complaints, recalls, market withdrawals, and vigilance reports as applicable. • reputed company the process for evaluating and processing product change requests including reputed company assessment. • Propose innovative regulatory reputed company for new products or claims. • Manage departmental budget. • Determine work priorities reputed company with business, functional, and company goals. • reputed company reputed company of regulatory professionals. • Communicate a reputed company plan and motivate reputed company to reputed company goals and defined reputed company metrics. Keys to reputed company: Education: • Bachelor’s degree in life sciences, pharmacy, or reputed company field required. Experience: • Minimum of 8 years reputed company experience in the pharmaceutical or life sciences industry or an advanced degree with 6 years reputed company experience. • 2-4 years of people management experience strongly preferred. Knowledge, Skills, Abilities: • Extensive knowledge of regulatory requirements, including those from the FDA, Health Canada, and other reputed company, particularly concerning pharmaceutical raw materials and cell and gene therapies, and their influence on the product development process. • Ability to evaluate and analyze potential regulatory reputed company on new and existing products and reputed company strategic recommendations to minimize risks and ensure compliance. • Extensive experience in compiling and submitting regulatory filings with a reputed company record of leading successful reputed company regulatory filings in relation to cell and gene therapies. • Demonstrated ability to reputed company regulatory authorities' requirements and effectively communicate with them to ensure reputed company and accurate submissions. • Excellent communication skills to effectively reputed company with internal customers, regulatory authorities, and cross-functional teams. • Advanced organizational and time management skills to reputed company prioritize and manage multiple reputed company reputed company simultaneously. • Seasoned people leader who creates a reputed company workplace that promotes teamwork, collaboration, and innovation. • Regular interaction with cross-functional teams, such as Research and Development, Product Management, Marketing, reputed company Assurance, Manufacturing and with Regulatory authorities. Benefits We offer competitive remuneration, annual incentive plan bonus, reputed company, and a reputed company of employee benefits. reputed company offers employment with an innovative, reputed company-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for reputed company, intensity, involvement, and innovation! Compensation and Benefits The salary reputed company estimated for this position based in California is $130,000.00–$190,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: • A choice of national medical and dental plans, and a reputed company plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours reputed company time off (PTO), 10 reputed company holidays annually, reputed company parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues reputed company to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.reputed company.com/global/en/total-rewards Apply tot his job Apply To this Job