Senior Manager, Regulatory Operations - Remote

Society for Conservation Biology; Washington (District of Columbia); Remote; USD 127,000 - 191,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Senior Manager of Regulatory Operations to oversee submission activities and ensure compliance with regulations. This role requires strong organizational and communication skills, along with a background in Regulatory Operations within the biotech or pharmaceutical industry. The position offers a flexible work environment, competitive compensation, and opportunities for professional growth.

Benefits

Professional growth opportunities

Inclusive and supportive work environment

Comprehensive benefits

Performance incentives

Commitment to diversity and community engagement

Qualifications

• 6+ years of Regulatory Operations experience in biotech/pharmaceutical industry.
• Proficiency with RIM systems, preferably Veeva.
• Knowledge of CTD/eCTD formats and global submission requirements.

Responsibilities

• Manage submission activities and regulatory information for global applications.
• Partner with Regulatory Affairs Leads for health authority submissions.
• Lead initiatives to improve processes within Regulatory Operations.

Skills

Organizational skills

Communication skills

Interpersonal skills

Attention to detail

Multitasking abilities

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

Microsoft Word

Adobe Acrobat

Veeva RIM

Job description

Senior Manager, Regulatory Operations - Remote

Employer: Agios Pharmaceuticals | Location: Washington, District of Columbia, 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 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 Make

We 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 Information

We 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.