Position Summary

The Manager, Regulatory Promotional Compliance and Labeling Operations role is responsible for supporting regulatory compliance review and approval of company promotional materials, leading FDA-OPDP 2253 submissions process, and managing labeling operations related tasks. The manager will be part of the global Medical, Legal, Regulatory (MLR) process, and accountable for ensuring all required revisions by MLR reviewers were implemented before approving promotional materials for dissemination or submission to Health Authorities as required. They will also support the end-to-end global labeling process by performing quality reviews of draft labels for all Acadia products both in development and on the market to ensure compliance with Health Authorities labeling requirements.

Primary Responsibilities

• Reviews all US, Canada, and EU promotional/non-promotional materials, including sales training and global promotional templates, to ensure required revisions by MLR reviewers were implemented before approving promotional materials for external dissemination or submission to health authorities as required.
• Collaborate with Marketing, Marketing Operations, and Regulatory Operations to ensure timely submission of all US promotional materials to FDA-OPDP prior to the first use date.
• Ensures compliance with the FDA-OPDP 2253 submission process for all ACADIA marketed products.
• Support MLR process optimization efforts to ensure compliance with Global Health Authorities requirements for submission of promotional materials as required.
• Support with formatting and QC of draft labeling text (e.g. USPI, PPI, Med Guide, EU SmPC, EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management.
• Support implementation of labeling review and approval process, including documentation of label history, LMT/ELC decisions, and exceptions from CCDS to facilitate end to end global labeling process.
• Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA, EMA and other applicable regulatory authorities.
• Support the development of annotated labels post approval and archiving labeling correspondence from Health Authorities.
• Other duties as required.

Education and Experience

Bachelor's degree in a scientific discipline or related field. Targeting 5 years of Regulatory Affairs experience. Must have a strong understanding of FDA Regulatory Advertising and Promotion regulations, FDA-OPDP 2253 submission process, and global regulatory labeling requirements. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Ability to interpret and implement Regulatory Health Authorities requirements as it pertains to labeling, and Advertising and Promotion of Pharmaceutical products.
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
• Self-organized, self-directing, and highly motivated.
• Strong critical thinking, problem solving abilities, and analytical skills.
• Knowledge of US and international regulations as they apply to Regulatory Affairs.
• Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content.
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
• Good verbal and written organizational and communication skills.

• Skilled at negotiating with business partners or management regarding matters of significance to the organization.
• Ability to adapt to changing priorities and prioritize work effectively.
• Ability to travel.

Scope

Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.

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.