19 Associate Director Regulatory Operations Jobs in Princeton, NJ
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Associate Director Regulatory Operations
$166k-220k (estimate)
Full Time | Pharmaceutical
1 Week Ago
ACADIA Pharmaceuticals is Hiring an Associate Director Regulatory Operations Near Princeton, NJ
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.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 Responsibilities
What we offer you (US-Based Employees):
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.
Primary Responsibilities
- Support 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 vendors
- Support oversight of the business aspects of Vault RIM such as user accounts, project dictionaries, document metadata, and organization
- Collaborate 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 necessary
- Offers document management expertise and assists with regulatory submission strategy as needed
- Interpret and enforce electronic regulatory submission standards, policies and operating procedure requirements
- Serve as a point of escalation for process and technical issues that arise during submission preparation and publishing
- Partner with IT and QA on the change management, release management, and ongoing validation of all Regulatory Operation computer systems
- Survey current and emerging regulatory guidance’s, best practices, and technology advances to make recommendations for systems and/or process projects and initiatives
- Lead development and maintain process and standards documents (e.g., SOPs, work instructions, checklists) related to document/submission publishing and regulatory systems
- Other duties as required
- Must have technical expertise in EDMS oversight
- Thorough knowledge of US and international regulations as they apply to Regulatory Affairs
- Ability to influence and partner cross-functionally
- Self-organized, self-directing, and highly motivated
- Strong critical thinking and analytical skills
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Good verbal and written organizational and communication skills
- Skilled at negotiating with business partners and influencing management regarding matters of significance
What we offer you (US-Based Employees):
- 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
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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$166k-220k (estimate)
POST DATE
06/21/2024
EXPIRATION DATE
07/12/2024
WEBSITE
acadia-pharm.com
HEADQUARTERS
SAN DIEGO, CA
SIZE
500 - 1,000
FOUNDED
1993
CEO
STEPHEN R DAVIS
REVENUE
$200M - $500M
INDUSTRY
Pharmaceutical
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The job skills required for Associate Director Regulatory Operations include Regulatory Affairs, Initiative, Planning, SOP, Influencing, Publishing, etc. Having related job skills and expertise will give you an advantage when applying to be an Associate Director Regulatory Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Associate Director Regulatory Operations. Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for Associate Director Regulatory Operations positions, which can be used as a reference in future career path planning. As an Associate Director Regulatory Operations, it can be promoted into senior positions as a Regulatory Affairs Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Associate Director Regulatory Operations. You can explore the career advancement for an Associate Director Regulatory Operations below and select your interested title to get hiring information.
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