Senior Manager, Regulatory Operations - Remote

Society for Conservation Biology; Boston (MA); Remote; USD 125,000 - 150,000; Full time

Job description

Senior Manager, Regulatory Operations - Remote

Employer: Agios Pharmaceuticals

Location: South Boston, Massachusetts, US

Salary: Competitive

Closing date: May 20, 2025

Sector: Consultancy/Private Sector

Field: Conservation science

Discipline: Administration/Operations

Job Level: Senior level

Employment Type: Full time

About Us:

Agios is a biopharmaceutical company committed to developing therapies for rare diseases. We foster a supportive, flexible environment where our team members can thrive and bring their whole selves to work. Our work impacts patients' lives through innovative treatments for conditions like hemolytic anemia, thalassemia, sickle cell disease, and more.

The Role:

We are seeking a dynamic Senior Manager of Regulatory Operations to join our Regulatory Affairs team. This role involves managing submission activities and regulatory information for global applications, ensuring compliance with international regulations, and collaborating with cross-functional teams in a fast-paced environment.

Key Responsibilities:

1. Partner with Regulatory Affairs Leads to plan and prepare global health authority submissions.
2. Support the Submission Coordinator in planning and executing filing timelines.
3. Manage submission deliverables within Veeva RIM, ensuring accuracy and timeliness.
4. Coordinate with external vendors for submission transmittal.
5. Archive communications and submissions in Veeva RIM.
6. Maintain records and support compliance with submission standards.
7. Lead initiatives to improve regulatory processes and systems.

Qualifications:

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 6+ years of Regulatory Operations experience in biotech/pharma.
• Proficiency with Microsoft Word, Adobe Acrobat, and RIM systems (Veeva preferred).
• Knowledge of CTD/eCTD formats and submission requirements.
• Excellent organizational, communication, and interpersonal skills.
• Ability to work independently and collaboratively in a dynamic environment.

Additional Information:

We encourage candidates who may not meet all requirements to apply, as we value diverse experiences and perspectives. This role can be remote or hybrid in the US, with some travel for company events.

We offer professional development, comprehensive benefits, competitive compensation, and a commitment to diversity and community involvement.