Please note that this position is based in either San Diego, CA or 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

• 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

Education/Experience/Skills

Bachelor’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 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

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 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.

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