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Acadia Pharmaceuticals Inc. · 1 day ago

Associate Director, Regulatory Affairs ROW

Princeton, New Jersey, United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$158K/yr - $195K/yr

8+ years exp

Acadia Pharmaceuticals is dedicated to advancing innovative treatments for underserved neurological and rare disease communities. The Associate Director, Regulatory Affairs ROW will be responsible for developing and executing global regulatory strategies and ensuring compliance for the company's products in various markets.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Provides regulatory strategic direction and support for assigned global development programs/development program activities and assists Sr. Regulatory Affairs staff with their development program activities and deliverables

Designs and implements regulatory strategies with Sr. Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management

Provides regulatory strategic direction to support early access programs in compliance with local laws and regulations

Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with global regulatory authorities outside of US and EU geographies

Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities intended to further the development of ACADIA development programs

With limited oversight, interacts effectively with cross functional project team members in order to communicate regulatory objectives/strategies for regulatory deliverables, including ensure timely, high-quality and content appropriateness of documentation supporting regulatory submissions, ensuring departmental timelines are achieved

Supports Sr. Regulatory AdPromo staff by assisting in the review of advertising and promotional pieces for completeness and compliance with established requirements, including but not limited to external communications materials, sales and marketing, training and product promotional strategies

Support Sr. Regulatory AdPromo staff by assisting in the review of communications related to early access programs to ensure compliance with local laws and regulations

Participates in Medical Review Committee to review medical information documents for completeness and compliance with established company requirements

Helps in establishment and execution of operational objectives of assigned and Sr. Staff projects

Assists in the preparation and maintenance of appropriate reports and other documents required to support or maintain regulatory development and marketing applications

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

Reviews SOPs pertaining to Regulatory Affairs

Keeps abreast of regulatory procedures and changes

Other responsibilities as assigned

Qualification

Regulatory drug developmentGlobal regulatory strategyProject ManagementMicrosoft OfficeAttention to detailCommunication skills

Required

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

Targeting 8 years of progressively responsible experience in the pharmaceutical or related industry; regulatory drug development experience is required

Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with global regulatory authorities outside of US and EU geographies

Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines

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

Must be able and willing to travel on occasion