*Temporary 1 year opportunity with potential to extend AND/OR go permanent*

This individual at the (Sr.) Manager or Associate Director level will support our Executive Director of Regulatory Affairs who is the regulatory lead on the DRP (Dementia-Related Psychosis) program. Job Description is subject to change based on experience of candidate.

Position Summary:

The Regulatory Affairs Senior Manager or Associate Director is responsible for assisting in the building and execution of global regulatory strategy pertaining to the development and marketing of Acadia projects and products.

This role will assist Sr. Regulatory Affairs Dept. Staff in the compilation of regulatory documentation to support US and global regulatory development investigative and marketing application submissions in compliance with corresponding regulations.

Primary Duties & Responsibilities:

Regulatory Development and Life Cycle Management

  • Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
  • Helps in the implementation of regulatory strategies to obtain and maintain investigative and marketing applications for assigned programs, as well as their life cycle management
  • Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
  • Experienced in building responses to inquiries from global regulatory authorities as well as assistance in the preparation and coordination of meetings with global regulatory authorities intended to further the development of ACADIA development programs
  • Interacts effectively with cross-functional project team members in order to communicate regulatory objectives/strategies for regulatory deliverables, including ensuring timely, high-quality and content appropriateness of documentation supporting regulatory submissions, ensuring departmental timelines are achieved
  • Supports planning of public databank submissions (i.e. clinicaltrials.gov) to ensure regulatory compliance
  • Represent department with support of Sr. Regulatory Affairs staff for internal audits as appropriate
  • Supports Sr. Regulatory AdPromo staff by assisting in the review of advertising and promotional pieces for completeness and compliance with established requirements as well as assisting in their regulatory submission and cataloging
  • Assists in the development and maintenance of labeling
  • Assists with FDA Advisory Committee preparation

Regulatory Submission Coordination

  • Helps in establishment and execution of operational objectives of multiple projects for which the role is supporting Sr. Regulatory Staff
  • Supports global clinical trial application (CTA) submissions and their maintenance, including the preparation and maintenance of CTA documentation, Annual Reports/Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs/CTAs
  • Supports regulatory marketing application and supplement submission teams for submission planning, building/tracking and execution
    • Interacts effectively with functional departments in order to facilitate documentation requirements for submissions, ensuring departmental timelines are achieved. Communicates and coordinates regulatory activities with other departments, as needed
    • Monitors and collects assigned deliverables required for regulatory submissions
    • Compiles all materials in an orderly fashion to facilitate timely submission to the FDA
    • Reviews submission materials for errors or other content issues prior to submission
  • Assists in the cataloging and maintenance of regulatory application submissions and correspondence
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
  • Coordinates and prepares regulatory document packages for regulatory meetings and submissions in alignment and compliance with local and regional registration requirements as well as with company policies
  • Keeps abreast of regulatory procedures and changes
  • Reviews SOPs pertaining to Regulatory Affairs


  • Science or healthcare related degree preferred, including BS, MS, MPH, PharmD, PhD or MD
  • 5-10 years of experience in the pharmaceutical or related industry; 2- 5 years regulatory drug development experience is required

Must possess:

  • Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents
  • Ability to understand and explain detailed regulatory affairs and compliance programs and/or issues
  • Ability to effectively present information to senior regulatory management, other departments or external groups
  • Ability to comply with changing regulatory procedures
  • Ability to adapt to changing priorities and prioritize work effectively
  • Strong Project Management capabilities
  • Excellent Microsoft Office skills


  • Provides proactive guidance to cross-functional team members based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects
  • With the support of Sr. Regulatory Affairs staff, assists in the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant global regulatory filings
  • Effectively participates in key meetings with global regulatory authorities to ensure full discussion of issues and opportunities
  • Demonstrated ability to routinely accept empowerment from Sr. Regulatory Affairs staff to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation
  • Assists Sr. Regulatory Affairs Staff in the AdPromo and labeling compliance review as part of the ACADIA Advertising and Promotion review process as well as supports AdPromo material submission and cataloging
  • Monitors and collects assigned deliverables required for regulatory submissions and assists Sr. Regulatory Affairs staff in project activities and Regulatory Affairs department deliverables

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.

ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Apply for this Job

* Required

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at ACADIA Pharmaceuticals are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 1/31/2020

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities1. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.