Associate Director, Regulatory Affairs ROW

Role Summary

The Associate Director, Regulatory Affairs ROW is responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and marketing of Acadia products, including regulatory compliance for advertising and promotion of marketed products. This role also supports compilation of regulatory documentation to support ex-US/EU regulatory development and marketing submissions, and supports regulatory needs for regional access and commercialization efforts. Based in Princeton, NJ, with a hybrid model requiring approximately 3 days per week in the office.

Responsibilities

• Provides regulatory strategic direction and support for assigned global development programs and assists senior regulatory staff with program activities and deliverables.
• Designs and implements regulatory strategies to obtain and maintain product investigative and marketing applications and their life cycle management.
• Provides regulatory strategic direction to support early access programs in compliance with local laws and regulations.
• Maintains strong understanding of regulatory requirements and emerging landscapes outside US and EU geographies.
• Responds to inquiries from global regulatory authorities and supports meetings to advance development programs.
• Interacts with cross-functional project teams to communicate regulatory objectives/strategies and ensure timely, high-quality documentation supporting regulatory submissions.
• Supports regulatory AdPromo staff by reviewing advertising and promotional pieces for completeness and compliance with requirements.
• Assists in reviewing communications related to early access programs to ensure regulatory compliance.
• Participates in Medical Review Committee to review medical information documents for completeness and compliance.
• Supports establishment and execution of operational objectives for assigned and senior staff projects.
• Assists in preparation and maintenance of reports and documents required to support regulatory development and marketing applications.
• Assists in cataloging and maintenance of regulatory submissions and correspondence.
• Maintains strong attention to detail in documenting, prioritizing, scheduling and meeting deadlines; reviews SOPs related to Regulatory Affairs.
• Keeps abreast of regulatory procedures and changes; performs other responsibilities as assigned.

Qualifications

• PharmD, PhD, or MD degree in a life sciences or healthcare field. Targeting 8 years of progressively responsible experience in the pharmaceutical or related industry; regulatory drug development experience is required. An equivalent combination of education and experience may be considered.

Skills

• Ability to read, analyze and interpret scientific and regulatory information.
• Ability to understand and explain detailed regulatory affairs and compliance programs and issues.
• Ability to present information effectively to senior regulatory management, other departments or external groups.
• Ability to comply with changing regulatory procedures and adapt to changing priorities.
• Strong project management capabilities.
• Excellent Microsoft Office skills.
• Must be able and willing to travel on occasion.

Education

• PharmD, PhD, or MD degree in a life science or healthcare field.

Additional Requirements

• Regular travel may be required; ability to travel independently overnight and/or work after hours as needed by travel schedules or business needs.
• Physical requirements include typical office activities; ability to lift up to 20 pounds occasionally.