Senior Manager, Regulatory Operations - Remote

Society for Conservation Biology; San Diego (CA); Remote; USD 127,000 - 191,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Manager of Regulatory Operations to oversee submission management and ensure compliance with global regulations. The ideal candidate will have extensive experience in regulatory operations and a strong attention to detail, contributing to the mission of improving patient outcomes through innovative therapies.

Benefits

Premium benefits package

Competitive performance-based compensation

Commitment to diversity

Psychological safety

Qualifications

• 6+ years of Regulatory Operations experience in biotech/pharmaceutical.
• Experience with CTD/eCTD format and regulatory submission requirements.
• Ability to work independently and as part of a team.

Responsibilities

• Manage submission deliverables and ensure compliance with regulations.
• Partner with Regulatory Affairs Lead(s) for global submissions.
• Lead Regulatory Operations initiatives and process improvements.

Skills

Attention to detail

Interpersonal skills

Organizational skills

Communication skills

Education

Bachelor's degree in life-sciences

Advanced degree preferred

Tools

Microsoft Word

Adobe Acrobat

Regulatory Information Management System (RIM)

Job description

Senior Manager, Regulatory Operations - Remote

Employer Agios Pharmaceuticals Location San Diego, California, US Salary Competitive Closing date May 20, 2025

View more categories View less categories Sector Consultancy/Private Sector Field Conservation science Discipline Administration/Operations Job Level Senior level Salary Type Salary Employment Type Full time

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases - and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company's leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Senior Manager of Regulatory Operations to join our growing Regulatory Affairs team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Senior Manager of Regulatory Operations is responsible for submission management activities and regulatory information management for global applications. This role ensures compliance with evolving global health authority/ICH regulations and guidelines for electronic submissions. The ideal candidate for this role is highly detail-oriented, excels at operational execution, and adept at collaborating with cross-functional teams in a dynamic and fast-paced environment.

What you will do:

• Partner with Regulatory Affairs Lead(s) to plan and prepare global health authority submissions.
• Partner and provide support to the Submission Coordinator as needed in the planning and execution of filing timelines.
• Manage submission deliverables, according to timelines, within Veeva RIM; ensure accuracy (advanced editing/formatting support of submission documents and document-level publishing).
• Oversee timely transmittal of submissions to global health authorities, coordinating activities with external publishing vendor.
• Archive health authority communications and submissions within Veeva RIM.
• Maintain records in Veeva RIM including health authority question and commitment records.
• Support and partner with Regulatory and cross-functional team members to ensure compliance with and provide guidance on submission standards and processes. Ensure strong communication to identify and address challenges and opportunities for efficiencies.
• Lead and contribute to Regulatory Operations initiatives (process changes and system implementations/enhancements); recommend and help implement associated process improvements.

What you bring:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred.
• 6+ years of Regulatory Operations experience in a biotech/pharmaceutical industry.
• Extensive experience with Microsoft Word and Adobe Acrobat (experience with StartingPoint templates and TRS/ISI Toolbox preferred).
• Experience using Regulatory Information Management System (RIM) (Veeva RIM experience preferred).
• Demonstrated knowledge of current CTD/eCTD format and regulatory submission requirements.
• Experience compiling/publishing global eCTD submissions.
• Ability to work independently as well as part of a team and with external partners.
• Strong attention to detail and the ability to multi-task in fast paced environment.
• Strong interpersonal skills and the ability to effectively work individually, within a cross-functional team, as well as with external partners and vendors.
• Excellent organizational and communication skills, both written and verbal.
• Positive attitude and proactive.

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

Work Location:

Location Agnostic: Work location for this role is based on employees individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description..

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• The current base salary range for this position is expected to be between $127,219 and $190,828 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

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