Senior Manager, Regulatory Operations - Remote

Society for Conservation Biology; Campbell (CA); Remote; USD 100,000 - 140,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Senior Manager of Regulatory Operations. This role involves overseeing submission activities and ensuring compliance with international regulations while collaborating with cross-functional teams. The position offers flexibility in location, with opportunities for professional development and a supportive workplace culture.

Benefits

Professional development opportunities

Comprehensive benefits package

Competitive compensation with performance incentives

Supportive, inclusive workplace culture

Qualifications

• 6+ years of Regulatory Operations experience in biotech/pharmaceutical industry.
• Proficiency with Regulatory Information Management Systems like Veeva RIM.
• Knowledge of CTD/eCTD formats and global submission requirements.

Responsibilities

• Manage submission activities and regulatory information for global applications.
• Plan and prepare global health authority submissions.
• Ensure compliance with submission standards and lead process improvements.

Skills

Attention to detail

Organizational skills

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Veeva RIM

Microsoft Word

Adobe Acrobat

Job description

Senior Manager, Regulatory Operations - Remote

Employer: Agios Pharmaceuticals | Location: Campbell, California, US | Salary: Competitive | Closing date: May 20, 2025

Sector: Consultancy/Private Sector | Field: Conservation science | Discipline: Administration/Operations | Job Level: Senior level | Salary Type: Salary | Employment Type: Full time

About Us

Agios is a biopharmaceutical company committed to connecting people and science. We foster a supportive, fun, and flexible environment where our team members bring their whole selves to work. We are dedicated to making a difference in the lives of patients with rare diseases through innovative therapies. Our pipeline includes treatments for hemolytic anemia, alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency, and MDS-associated anemia.

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. Plan and prepare global health authority submissions in partnership with Regulatory Affairs Leads.
2. Support the Submission Coordinator in planning and executing filing timelines.
3. Manage submission deliverables within Veeva RIM, ensuring accuracy and timeliness.
4. Oversee submission transmittal to global health authorities, coordinating with external vendors.
5. Archive health authority communications and submissions in Veeva RIM.
6. Maintain records in Veeva RIM, including questions and commitments.
7. Ensure compliance with submission standards, providing guidance and support to the team.
8. Lead initiatives for process improvements and system enhancements in 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 Regulatory Information Management Systems like Veeva RIM.
• Knowledge of CTD/eCTD formats and global submission requirements.
• Ability to work independently and collaboratively, with strong attention to detail.
• Excellent organizational and communication skills.

Additional Information

We encourage candidates who may not meet every requirement to apply. We value diversity and are committed to an inclusive environment. This role is location flexible: remote in the US or hybrid at our Cambridge headquarters, with travel as needed.

Benefits

• Professional development opportunities.
• Comprehensive benefits package.
• Competitive compensation with performance incentives.
• Supportive, inclusive workplace culture.