ACADIA Pharmaceuticals
Associate Director Regulatory Operations
ACADIA Pharmaceuticals, San Diego, California, United States, 92189
About Acadia PharmaceuticalsAcadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.Please note that this position is based San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations. Supports the development of Regulatory Operations procedures and practices. The individual will survey emerging technologies, business practices related to regulatory information management systems, responsible for the assembly, publishing, QC, submission, and archiving of regulatory filings to Health Authorities (HA).Primary ResponsibilitiesSupport Acadia's regulatory systems portfolio including Veeva Vault Submissions, IQVIA RIM Smart, and other utilities and tools used in the management of regulatory information and submission production, partnering with IT, and vendorsSupport oversight of the business aspects of Vault RIM such as user accounts, project dictionaries, document metadata, and organizationCollaborate with cross-functional team members and external contractors/vendors/consultants to support the planning, preparation, formatting, timely delivery of documents, publishing, QC, submission and archiving of regulatory submissions (i.e., INDs/CTAs/NDAs/MAAs and amendments/supplements, responses to health authority requests for information, health authority briefing documents, etc)Responsible for the development, implementation, and rollout of training to the organization on Regulatory Operations processes and systems, including but not limited to Starting Point Templates, existing processes or systems, the introduction of new processes and/or systems, and the training of new employees as necessaryOffers document management expertise and assists with regulatory submission strategy as neededInterpret and enforce electronic regulatory submission standards, policies and operating procedure requirementsServe as a point of escalation for process and technical issues that arise during submission preparation and publishingPartner with IT and QA on the change management, release management, and ongoing validation of all Regulatory Operation computer systemsSurvey current and emerging regulatory guidance's, best practices, and technology advances to make recommendations for systems and/or process projects and initiativesLead development and maintain process and standards documents (e.g., SOPs, work instructions, checklists) related to document/submission publishing and regulatory systemsOther duties as required
Education/Experience/SkillsBachelor's degree in scientific discipline or related field. Targeting 8 years of regulatory operations experience within the pharmaceutical or biotech industry. Must have strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools. An equivalent combination of relevant education and experience may be considered.Must have technical expertise in EDMS oversightThorough knowledge of US and international regulations as they apply to Regulatory AffairsAbility to influence and partner cross-functionallySelf-organized, self-directing, and highly motivatedStrong critical thinking and analytical skillsDemonstrated ability to contribute to a continuous learning and process improvement environmentGood verbal and written organizational and communication skillsSkilled at negotiating with business partners and influencing management regarding matters of significance
Physical RequirementsWhile 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 and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.#LI-HYBRID#LI-BG1In 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 $140,000-$174,400 USD
What we offer you (US-Based Employees):Competitive base, bonus, new hire and ongoing equity packagesMedical, dental, and vision insurance401(k) Plan with a fully vested company match 1:1 up to 5%Employee Stock Purchase Plan with a 2-year purchase price lock-in15+ vacation days14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st10 days of paid sick timePaid parental leaveTuition 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 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.
Education/Experience/SkillsBachelor's degree in scientific discipline or related field. Targeting 8 years of regulatory operations experience within the pharmaceutical or biotech industry. Must have strong expertise in the eCTD process, oversight of electronic document management systems, and publishing software and tools. An equivalent combination of relevant education and experience may be considered.Must have technical expertise in EDMS oversightThorough knowledge of US and international regulations as they apply to Regulatory AffairsAbility to influence and partner cross-functionallySelf-organized, self-directing, and highly motivatedStrong critical thinking and analytical skillsDemonstrated ability to contribute to a continuous learning and process improvement environmentGood verbal and written organizational and communication skillsSkilled at negotiating with business partners and influencing management regarding matters of significance
Physical RequirementsWhile 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 and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.#LI-HYBRID#LI-BG1In 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 $140,000-$174,400 USD
What we offer you (US-Based Employees):Competitive base, bonus, new hire and ongoing equity packagesMedical, dental, and vision insurance401(k) Plan with a fully vested company match 1:1 up to 5%Employee Stock Purchase Plan with a 2-year purchase price lock-in15+ vacation days14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st10 days of paid sick timePaid parental leaveTuition 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 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.