Manager, Regulatory Affairs, Operations

ACADIA Pharmaceuticals Inc.; Princeton (NJ); Hybrid; USD 104,000 - 130,000; Full time

Benefits offered by this job

Competitive base salary

Bonus eligibility

Equity awards

Medical, dental, and vision insurance

Employer-paid life, disability, travel

401(k) with company match

Employee Stock Purchase Plan

15+ vacation days

Paid holidays

Paid sick time

Parental leave

Tuition assistance

Job summary

Acadia Pharmaceuticals Inc. seeks a Manager, Regulatory Operations to oversee planning, publishing, tracking, and lifecycle management of global regulatory submissions.

You will collaborate with Regulatory Affairs, IT, Quality, and vendors to ensure compliant, inspection-ready content and robust RIM processes. The role supports RIM capabilities, metadata governance, and submission lifecycle management, with a focus on eCTD, regulatory standards, and continuous improvement.

Qualifications

• Bachelor's degree in regulatory affairs, life sciences, information management, or a related field.
• 5 years of progressively responsible experience in Regulatory Operations, regulatory submissions, regulatory systems, document management, and/or Regulatory Information Management in biotech/pharma.
• Hands-on experience supporting electronic regulatory submissions and working with validated regulatory technology platforms; experience with a RIM suite is strongly preferred.
• Experience with global submission requirements, eCTD, regulatory document standards, metadata, records management, and submission lifecycle management.
• Experience supporting system changes, testing, validation or assurance activities, training, metrics, and process improvement.
• Strong understanding of Regulatory Operations business processes and the functional document types that comprise global regulatory submissions (clinical, nonclinical, quality, labeling, administration).
• Working knowledge of RIM data models and processes (regulatory activities, applications, submissions, registrations, commitments, correspondence, document metadata, reporting).
• Excellent written and verbal communication; ability to train users, facilitate discussions, influence without authority.
• Demonstrated project management, organization, prioritization, and problem-solving in deadline-driven environments.
• Attention to detail, integrity, accountability, and commitment to quality and compliance.
• Ability to work independently with moderate guidance while collaborating across functions and external partners.
• Proficiency with Microsoft Office and PDF tools; experience with regulatory publishing and RIM platforms preferred.
• Willingness to travel domestically and internationally.

Responsibilities

• Plan, prepare, publish, quality-check, dispatch, and track electronic regulatory submissions per global requirements and timelines.
• Coordinate submission activities with Regulatory Affairs leads, authors, reviewers, vendors, and stakeholders; identify risks and impacts.
• Ensure submission-ready documents meet formatting, metadata, and lifecycle requirements (eCTD, regional standards).
• Support operation of the RIM ecosystem, including document management, submissions, registrations, and correspondence.
• Monitor RIM data for completeness and timeliness; coordinate remediation with data owners.
• Ensure metadata for regulatory objects is entered and maintained for downstream reporting and traceability.
• Partner to define, document, and improve regulatory processes, work instructions, and data standards.
• Provide role-based training and technical support for regulatory systems and data practices.
• Support periodic releases/upgrades to validated regulatory systems.
• Contribute to inspection readiness with complete regulatory records and evidence.
• Stay current on evolving global regulations and best practices affecting submissions and RIM.
• Perform other duties and special projects as assigned.

Skills

Regulatory submissions

RIM concepts

Document management

Project management

Communication

Training & coaching

Process improvement

Travel flexibility

Education

Bachelor's degree in regulatory affairs, life sciences, information management, or related field

5 years of regulatory operations experience

Tools

Microsoft Office

PDF tools

RIM platforms

Job description

Please note that this position can be based in San Diego, CA, San Francisco, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Manager, Regulatory Operations supports the planning, preparation, publishing, submission, tracking, and lifecycle management of global regulatory submissions. The role partners with Regulatory Affairs, cross-functional contributors, Information Technology, Quality, and external vendors to ensure submission content and regulatory information are complete, accurate, timely, inspection-ready, and compliant with applicable health authority requirements and internal procedures. The Manager also supports effective use and continuous improvement of Regulatory Information Management (RIM) capabilities, including document management, submission planning and tracking, registrations, health authority correspondence, reporting, and data quality oversight.

Primary Responsibilities

• Plan, prepare, publish, quality-check, dispatch, and track electronic regulatory submissions in accordance with global regulatory requirements, internal standards, and committed timelines
• Coordinate submission activities with Regulatory Affairs leads, authors, reviewers, vendors, and other stakeholders; proactively identify risks, dependencies, and timeline impacts
• Ensure submission-ready documents meet applicable formatting, technical, metadata, and lifecycle requirements, including eCTD and other regional electronic submission standards
• Support the operation and administration of the RIM ecosystem, which may include electronic document management, submissions, submissions archive, registrations, regulatory activities, commitments, and health authority correspondence
• Monitor RIM data for completeness, accuracy, consistency, and timeliness from regulatory planning through submission and health authority interaction; coordinate remediation with data owners
• Ensure required metadata are entered and maintained for regulatory objects, documents, activities, submissions, applications, registrations, and correspondence to support downstream processes, reporting, and traceability
• Partner with stakeholders to define, document, and improve regulatory processes, work instructions, job aids, controlled procedures, and data standards
• Provide role-based training, coaching, and technical support for regulatory systems, submission processes, document standards, and RIM data practices
• Support periodic releases, upgrades, and enhancements to validated regulatory systems
• Contribute to inspection readiness by ensuring regulatory records, submission archives, system documentation, and operational evidence are complete, accessible, and maintained in accordance with procedures
• Stay current on evolving global regulations, guidance, industry standards, and best practices affecting regulatory submissions, document management, and RIM
• Perform other duties and special projects as assigned

Education/Experience/Skills

• Bachelor's degree in regulatory affairs, life sciences, information management, or a related field. An equivalent combination of relevant education and experience may be considered
• Targeting 5 years of progressively responsible experience in Regulatory Operations, regulatory submissions, regulatory systems, document management, and/or Regulatory Information Management in the biopharmaceutical or life sciences industry
• Hands-on experience supporting electronic regulatory submissions and working with validated regulatory technology platforms; experience with a RIM suite is strongly preferred
• Experience with global submission requirements, eCTD, regulatory document standards, metadata, records management, and submission lifecycle management
• Experience supporting system changes, testing, validation or assurance activities, training, metrics, and process improvement
• Strong understanding of Regulatory Operations business processes and the functional document types that comprise global regulatory submissions, including clinical, nonclinical, quality, labeling, and administrative content
• Working knowledge of RIM data models and processes, including regulatory activities, applications, submissions, registrations, commitments, correspondence, document metadata, and reporting
• Excellent written and verbal communication skills, including the ability to train users, facilitate discussions, and influence without direct authority
• Demonstrated project management, organization, prioritization, and problem-solving skills in a deadline-driven environment with changing priorities
• High attention to detail, sound judgment, accountability, integrity, and a strong commitment to quality and compliance
• Ability to work independently with moderate guidance while collaborating effectively across functions and with external partners
• Proficiency with Microsoft Office applications and PDF tools; experience with regulatory publishing and RIM platforms is preferred
• Willingness and ability to travel domestically and internationally as needed

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$103,800 - $129,700 USD

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13-15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [e-mail] or 858-261-2923.

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

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