Assoc Dir Regulatory Affairs at Arcutis Biotherapeutics Inc – Westlake Village, California

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.

Roles & Responsibilities

1. 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.).
2. Provides expertise in translating regulatory requirements into practical, workable plans.
3. Provides regulatory support and guidance to product development teams, project teams, and ex-US development partners.
4. Provides input on key development documents included in INDs and CTA, such as clinical protocols, study reports, investigational brochures.
5. 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.
6. Contributes to regulatory activities for assigned programs in line with U.S., ex-U.S., ICH and other applicable requirements.
7. Ensures that regulatory documents are accurate, complete and verifiable and in compliance with regulatory requirements.
8. Provides interpretation of and advice regarding regulations, directives and guidance.
9. Assists in the development of responses to requests for information from regulatory authorities ensuring consistent positions are presented in responses.
10. Other duties may be assigned.

Job Complexity, Discretion and Interaction

Represents Regulatory Affairs at Team meetings. Communicates strategic and tactical issues to management. Erroneous decisions could have a significant impact on the success of Arcutis’ clinical programs. Interacts internally with all levels of staff, including the company’s leadership team. Interacts with external people and organizations, including both U.S. and ex-U.S. regulatory agencies.

Education & Licenses and Experience

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.

Competencies & Skills

• 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

Why Join Us?
Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!

This job description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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