*Temporary 1 year opportunity with potential to extend AND/OR go permanent*

This individual at the (Sr.) Manager or Associate Director level will support our Executive Director of Regulatory Affairs who is the regulatory lead on the DRP (Dementia-Related Psychosis) program. Job Description is subject to change based on experience of candidate.

Position Summary:

The Regulatory Affairs Senior Manager or Associate Director is responsible for assisting in the building and execution of global regulatory strategy pertaining to the development and marketing of Acadia projects and products.

This role will assist Sr. Regulatory Affairs Dept. Staff in the compilation of regulatory documentation to support US and global regulatory development investigative and marketing application submissions in compliance with corresponding regulations.

Primary Duties & Responsibilities:

Regulatory Development and Life Cycle Management

  • Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
  • Helps in the implementation of regulatory strategies to obtain and maintain investigative and marketing applications for assigned programs, as well as their life cycle management
  • Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
  • Experienced in building responses to inquiries from global regulatory authorities as well as assistance in the preparation and coordination of meetings with global regulatory authorities intended to further the development of ACADIA development programs
  • Interacts effectively with cross-functional project team members in order to communicate regulatory objectives/strategies for regulatory deliverables, including ensuring timely, high-quality and content appropriateness of documentation supporting regulatory submissions, ensuring departmental timelines are achieved
  • Supports planning of public databank submissions (i.e. clinicaltrials.gov) to ensure regulatory compliance
  • Represent department with support of Sr. Regulatory Affairs staff for internal audits as appropriate
  • Supports Sr. Regulatory AdPromo staff by assisting in the review of advertising and promotional pieces for completeness and compliance with established requirements as well as assisting in their regulatory submission and cataloging
  • Assists in the development and maintenance of labeling
  • Assists with FDA Advisory Committee preparation

Regulatory Submission Coordination

  • Helps in establishment and execution of operational objectives of multiple projects for which the role is supporting Sr. Regulatory Staff
  • Supports global clinical trial application (CTA) submissions and their maintenance, including the preparation and maintenance of CTA documentation, Annual Reports/Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs/CTAs
  • Supports regulatory marketing application and supplement submission teams for submission planning, building/tracking and execution
    • Interacts effectively with functional departments in order to facilitate documentation requirements for submissions, ensuring departmental timelines are achieved. Communicates and coordinates regulatory activities with other departments, as needed
    • Monitors and collects assigned deliverables required for regulatory submissions
    • Compiles all materials in an orderly fashion to facilitate timely submission to the FDA
    • Reviews submission materials for errors or other content issues prior to submission
  • Assists in the cataloging and maintenance of regulatory application submissions and correspondence
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
  • Coordinates and prepares regulatory document packages for regulatory meetings and submissions in alignment and compliance with local and regional registration requirements as well as with company policies
  • Keeps abreast of regulatory procedures and changes
  • Reviews SOPs pertaining to Regulatory Affairs

Education/Experience/Skills:

  • Science or healthcare related degree preferred, including BS, MS, MPH, PharmD, PhD or MD
  • 5-10 years of experience in the pharmaceutical or related industry; 2- 5 years regulatory drug development experience is required

Must possess:

  • Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents
  • Ability to understand and explain detailed regulatory affairs and compliance programs and/or issues
  • Ability to effectively present information to senior regulatory management, other departments or external groups
  • Ability to comply with changing regulatory procedures
  • Ability to adapt to changing priorities and prioritize work effectively
  • Strong Project Management capabilities
  • Excellent Microsoft Office skills

Scope:

  • Provides proactive guidance to cross-functional team members based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects
  • With the support of Sr. Regulatory Affairs staff, assists in the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant global regulatory filings
  • Effectively participates in key meetings with global regulatory authorities to ensure full discussion of issues and opportunities
  • Demonstrated ability to routinely accept empowerment from Sr. Regulatory Affairs staff to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation
  • Assists Sr. Regulatory Affairs Staff in the AdPromo and labeling compliance review as part of the ACADIA Advertising and Promotion review process as well as supports AdPromo material submission and cataloging
  • Monitors and collects assigned deliverables required for regulatory submissions and assists Sr. Regulatory Affairs staff in project activities and Regulatory Affairs department deliverables

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.

ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

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