Regulatory Affairs Associate Operations at Acadia Pharmaceuticals Inc.

Princeton, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Apr, 26

Salary

100000.0

Posted On

27 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

eCTD Guidelines, Regulatory Information Management Systems, Document Formatting, Quality Control, Collaboration, Communication, Project Management, Document Management Systems, Computer System Validation, Change Control, Regulatory Submissions, Technical Writing, Acrobat, Veeva Vault RIM, IQVIA RIM Smart, Clinical Study Reports

Industry

Pharmaceutical Manufacturing

Description

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 is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. Position Summary The Regulatory Operations Associate is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices. Primary Responsibilities Using Acadia’s eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practices. For authored documents, ensure formatting is applied consistently according to Acadia’s Style Guide. As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness. QC published eCTD submissions and reports, working collaboratively with teammates to resolve findings and issues. Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM. For clinical study reports, deliver Regulatory Operations kickoff slides (covering use of Veeva Vault RIM and tracking of appendices). For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion. As needed, work with system business owners, IT, and QA to support system. implementations and updates including execution of validation scripts Other responsibilities as assigned. Education/Experience/Skills Bachelor’s degree in a life science, information technology, business administration or a related field. Targeting 3 years of progressively responsible experience in regulatory operations or relevant function, preferably in a pharmaceutical or biotech environment. An equivalent combination of relevant education and experience may be considered. Key Skills: Thorough working knowledge of eCTD guidances (e.g., ICH, FDA, EMA, etc.), requirements, and technologies. Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems. Demonstrated ability to work collaboratively with IT, QA, and vendors to develop, implement, and maintain regulatory systems. Working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Acrobat, DXC Toolbox, authoring templates). Understanding of computer system validation principles and change control processes. Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports. Demonstrated ability to effectively communicate in written and verbal media concepts related to regulatory systems and electronic submissions Ability to manage multiple priorities and work cross-functionally in a fast-paced environment. Must be able and willing to travel on occasion. 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 $80,000—$100,000 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 talentacquisition@acadia-pharm.com 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. Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy. 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.

Responsibilities

The Regulatory Operations Associate is responsible for publishing, quality control, and transmittal of eCTD submissions, ensuring compliance with health authority guidelines. The role also involves collaborating with authors and contributors to prepare and manage regulatory documents and reports.