Associate Director Regulatory Affairs

Arcutis Biotherapeutics

About The Position

In support of Arcutis’ development programs, the Associate Director, Regulatory Affairs develops and implements regulatory strategies, assists in the timely preparation, review and submission of documents to regulatory authorities, and maintains compliance with relevant requirements.

Requirements

Typically requires a Bachelor’s degree in a scientific discipline and at least 8 years of related experience, or the equivalent combination of education and experience.
Strong Regulatory knowledge (US/ex-US experience, including emerting markets preferred).
Experience in the preparation and submission of regulatory documents
Experience with investigational drugs to include submissions of BLAs/NDAs and lifecycle management.
Ability to work in a fast-paced, dynamic environment with minimal supervision
Ability to adapt well under pressure
Ability to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner
Strong collaboration skills
Effective verbal and written communication skills
Proficient in the use of business productivity software (Excel, Word, PowerPoint, etc.)
Travel may be required

Responsibilities

Implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, and life cycle maintenance, (e.g. DSUR, Annual Reports, etc.).
Provides expertise in translating regulatory requirements into practical, workable plans.
Provides regulatory support and guidance to product development teams, project teams, and ex-US development partners.
Provides input on key development documents included in INDs and CTA, such as clinical protocols, study reports, investigational brochures.
Assists in the planning, preparation and review of submissions to both U.S. and ex-U.S. regulatory agencies throughout the life cycle of assigned programs. Represent regulatory affairs for ex-US submissions managed by assigned CROs.
Contributes to regulatory activities for assigned programs in line with U.S., ex-U.S., ICH and other applicable requirements.
Ensures that regulatory documents are accurate, complete and verifiable and in compliance with regulatory requirements.
Provides interpretation of and advice regarding regulations, directives and guidance.
Assists in the development of responses to requests for information from regulatory authorities ensuring consistent positions are presented in responses.
Other duties may be assigned.