Senior Director Regulatory Operations

Regulatory Affairs                 ·            Princeton, New Jersey, United States              ·          Full time

The Senior Director of Regulatory Operations provides leadership in creating, overseeing, trouble-shooting, training, and managing electronic publications and filing processes for global regulatory submissions.  Works with Regulatory Affairs and Technical Function authors as well as Regulatory Agencies to ensure that documents and submissions align with regulatory and company guidance/specifications.

Primary Responsibilities

• Provides oversight of and development of strategies related to electronic submission publishing (eCTD and other formats as required), regulatory information management, and submission management
• Leads publishing team responsible for worldwide regulatory electronic submissions ensuring health authority, ICH, and other standards organizations’ requirements are met
• Leads in the development of processes for departmental Work Instruction Documents outlining the generation of electronic submission-ready documents. This includes providing training and technical/document support to internal teams and external contractors, and supporting various task force activities related to various submission types
• Works cross-functionally to implement and maintain processes and quality control checks, ensuring all information provided in electronic submissions is accurate, complete, and meets regulatory specifications
• Represents Regulatory Affairs on systems projects, including Acadia’s IT and QA functions to define user requirements, select new systems, develop implementation/validation plans, and develop end-user training for Regulatory Affairs systems
• Works with Regulatory Affairs users, IT, and QA to maintain Regulatory Affairs systems to assess and implement configuration changes, and upgrades
• Provide overall business-side management of Regulatory Affairs systems and tools including, but not limited to Veeva Vault RIM, Extedo eCTDManager, Adobe Acrobat, Parexel SmartDesk, DXC Toolbox, GlobalSubmit eCTD Viewer and Validator, and ESG software
• Ensures Acadia systems, business processes, and regulatory submissions remain aligned with health authority and ICH technical and data standards requirements (eg CDISC, SEND)including working with key partners in Regulatory Affairs and other functional areas to ensure standards are adopted
• Performs other duties as assigned

Education/Experience/Skills

• Bachelor’s degree in a life science or related field. An equivalent combination of relevant education and applicable job experience may be considered 
• Targeting 12 years of progressively responsible experience, with 8 in a leadership role preferably in Regulatory Operations with a focus on electronic submissions, systems, and submission management
• Solid understanding of different functional document types that comprise eCTD regulatory submissions including clinical documents and other reports
• Strong understanding of electronic content/document management systems
• Ability to communicate clearly and concisely, both in writing & verbally, with others in a professional manner
• Keep abreast and analyze of submission and data standards, regulatory policies, procedures, security standards, GMP, and GCP
• Ability to work cross-functionally to tackle complex business process and technical problems, calling out concerns to senior management as appropriate
• Ability to schedule team priorities with minimal direction
• Strong understanding of the software development lifecycle and/or implementation of validated computer systems
• Proven track record of mentoring and developing team members

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.

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What we offer you:

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• 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
• 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave
• Tuition assistance

EEO Statement:

Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single 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 would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it 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 accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

Notice for California Applicants: Please see our California Applicant Privacy Notice 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 absence of an executed search agreement will not obligate Acadia in any way with the 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.

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