Senior Manager, Regulatory Operations - Remote

Company: Society for Conservation Biology
Location: Washington
Posted on: May 23, 2025

Job Description:

Senior Manager, Regulatory Operations - RemoteEmployer: Agios Pharmaceuticals - Location: Washington, District of Columbia, US - Salary: Competitive - Closing date: May 20, 2025Sector: Consultancy/Private Sector - Field: Conservation science - Discipline: Administration/Operations - Job Level: Senior level - Salary Type: Salary - Employment Type: Full timeAbout UsAgios is a biopharmaceutical company driven by connections. We foster a supportive, fun, and flexible environment where employees are encouraged to bring their whole selves to work. We are committed to our work, each other, and the patients we serve. Our teams build strong relationships with patient communities, healthcare professionals, partners, and colleagues to discover, develop, and deliver therapies for rare diseases. Currently, in the U.S., we market a first-in-class PK activator for hemolytic anemia in adults with PK deficiency. Building on our leadership in cellular metabolism, we are advancing a robust pipeline of investigational medicines for conditions like thalassemia, sickle cell disease, pediatric PK deficiency, and MDS-associated anemia.The Impact You Will MakeWe are seeking a dynamic Senior Manager of Regulatory Operations to join our Regulatory Affairs team. This role is vital in managing submission activities and regulatory information for global applications, ensuring compliance with evolving regulations. The ideal candidate is detail-oriented, excels in operations, and collaborates well in a fast-paced environment.Key Responsibilities

• Partner with Regulatory Affairs Leads to plan and prepare global health authority submissions.
• Support the Submission Coordinator in planning and executing filing timelines.
• Manage submission deliverables within Veeva RIM, ensuring accuracy and timely transmittal to global health authorities.
• Archive communications and submissions in Veeva RIM.
• Maintain records and support compliance with submission standards.
• Lead initiatives to improve processes and systems within Regulatory Operations.Qualifications
  • Bachelor's degree in life sciences or related field; advanced degree preferred.
  • 6+ years of Regulatory Operations experience in biotech/pharmaceutical industry.
  • Proficiency with Microsoft Word, Adobe Acrobat, and experience with RIM systems (Veeva preferred).
  • Knowledge of CTD/eCTD formats and global submission requirements.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to work independently and in teams, with attention to detail and multitasking abilities.Additional InformationWe value diverse experiences and encourage candidates who may not meet every requirement to apply. Our work location is flexible: remote within the US or hybrid at our Cambridge headquarters. Travel may be required for certain events.What We Offer
    • Professional growth opportunities.
    • Inclusive and supportive work environment.
    • Comprehensive benefits and competitive compensation.
    • Salary range: $127,219 - $190,828, based on experience and qualifications.
    • Performance incentives, psychological safety, commitment to diversity and community engagement.
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Keywords: Society for Conservation Biology, Arlington , Senior Manager, Regulatory Operations - Remote, Executive , Washington, Virginia