Manager, Regulatory Affairs, Operations

Regulatory Jobs; Princeton (NJ); Ibrido; USD 104.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive base salary

Medical, dental, and vision insurance

401(k) plan with company match

Paid vacation days

Paid holidays

Descrizione del lavoro

Acadia Pharmaceuticals is seeking a Manager, Regulatory Operations to lead planning, publishing, submission tracking, and lifecycle management of global regulatory submissions. The role partners with Regulatory Affairs, IT, Quality, and external vendors to ensure submission content and regulatory information are complete, accurate, timely, inspection-ready, and compliant with health authority requirements.

The position also supports the operation and continuous improvement of Regulatory

Competenze

• Bachelor's degree in regulatory affairs, life sciences, information management, or a related field
• 5 years of experience in Regulatory Operations or related roles
• Hands-on experience with electronic regulatory submissions and validated regulatory technology platforms
• Experience with global submission requirements, eCTD, metadata and lifecycle management
• Strong communication, training, and project management skills

Mansioni

• Plan, prepare, publish, quality-check, and track electronic regulatory submissions per global/regulatory requirements
• Coordinate submission activities with Regulatory Affairs, authors, reviewers, vendors and stakeholders
• Ensure documents meet formatting, metadata, and lifecycle requirements including eCTD standards
• Support operation and administration of the RIM ecosystem and data quality oversight
• Monitor RIM data for completeness and accuracy from planning to health authority interaction

Conoscenze

Regulatory submissions

RIM platforms

Cross-functional collaboration

Documentation management

Project management

Attention to detail

Communication skills

Formazione

Bachelor's degree in regulatory affairs

Strumenti

RIM software tools

eCTD knowledge

Descrizione del lavoro

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.

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.

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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.

California Applicants: Please see Additional Information for California Residents within our Privacy Policy.

Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.

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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.