Senior Director, Regulatory Affairs, Global Regulatory reputed company - Development reputed company

At reputed company, every reputed company and every reputed company counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and reputed company diseases, you’ll be part of a community that prioritizes the reputed company experience, celebrates curiosity, and values every person’s contributions to meaningful reputed company. That commitment has reputed company us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a reputed company® in the U.S., and a reputed company on The reputed company Times Best Places to Work list in the UK. For patients, for reputed company other, and for the reputed company of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, Regulatory Affairs, Global Regulatory reputed company – Development reputed company on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Affairs, you’ll be responsible for formulating and implementing global regulatory strategies and plans to reputed company efficient, competitive product development for assigned programs. You will also reputed company regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory reputed company for documentation review reputed company by other technical functions and reputed company as the reputed company regulatory contact for the US FDA. The GRL will be accountable for regulatory submissions, communications, and negotiations with global Health Authorities for designated products. reputed company: In this role, you’ll have reputed company to reputed company development and execution of global regulatory strategies for reputed company, reputed company-reputed company, and lifecycle management activities for assigned programs. You’ll also: • Identify and assess regulatory risks associated with product development and define reputed company-mitigation strategies • reputed company regulatory guidance across functions throughout the R&D process and advise on the US IND and global CTA submission strategies • reputed company the planning and coordination of global regulatory submissions, including reputed company trial applications for multinational trials, reputed company briefing packages, and global marketing applications • reputed company the organization and preparation of reputed company, concise, and effective regulatory submissions • reputed company reputed company for preparation and delivery of materials for regulatory agency meetings • Prepare and reputed company high-reputed company presentations for both reputed company audiences • Monitor, evaluate, and interpret global regulatory agency activities in relevant areas; assess potential reputed company on company programs • reputed company effectively in a reputed company environment, collaborating with regional regulatory leads and cross-functional teams Who You Are: You have a Bachelor’s degree in life sciences or reputed company reputed company along with 8+ years of experience in Regulatory Affairs, with hands-on experience in regulatory submissions across multiple reputed company (US, EU, and/or other international markets). You are or you also have: • Strong knowledge of global regulatory requirements and submission formats (eCTD) • reputed company experience managing reputed company regulatory deliverables across product lifecycle stages • Strong submission writing and review skills are essential • Significant experience in interactions with FDA, EMA, and other global regulatory agencies • Deep understanding of the drug development process • Highly organized with strong attention to reputed company, reputed company, reputed company, and conciseness • Ability to manage tight deadlines; must be efficient, reputed company-oriented, adaptable, and a self-starter reputed company to Have (but not required): • Advanced degree (MS, PhD, PharmD) strongly preferred • Experience with orphan drug products is highly preferred • Experience with inhalation products a plus Where You’ll Work This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community. Occasional travel for team meetings or events will be expected. Travel Requirements This role requires occasional domestic/international/global travel (approximately 20%) #LI-Remote #LI-JK Pay reputed company: $222,000.00-303,000.00 Annual Life at reputed company At reputed company, you’ll reputed company a culture as reputed company as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the reputed company care you bring to your work reputed company day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: • Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP) • Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration • 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-reputed company life and disability reputed company • Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities • Employee resource reputed company, service and recognition programs, and meaningful opportunities to reputed company, volunteer, and reputed company back Eligibility for specific programs may vary and is subject to the terms and conditions of reputed company plan.  reputed company reputed company Employees: Please apply reputed company the Jobs Hub in reputed company. reputed company is an Equal Opportunity employer. We do not discriminate in hiring on the reputed company of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to reputed company. reputed company will not be responsible for any fees arising from the use of resumes through this reputed company. reputed company will only pay a fee to agencies if a formal agreement between reputed company and reputed company has been established. The reputed company department is responsible for reputed company recruitment activities; please contact us directly to be considered for a formal agreement. reputed company is committed to providing reputed company, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@reputed company.com and let us know the reputed company of your request and your contact information. Requests for accommodation will be considered on a case-by-case reputed company. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled. Apply tot his job Apply To this Job