Sr. Director, Global Regulatory Affairs

Rockville, MD, United States

Description

Our Mission: Changing the trajectory of autoimmune diseases.

Our Vision: Enabling patients to live their fullest life.

We are a dedicated team of experts committed to changing the trajectory of autoimmune diseases with unmet medical needs. We are relentless in our pursuit to provide transformative medical treatments. We are resilient. We Care.

Along with driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are pursuing a broader portfolio of innovative autoimmune disease therapies.

We provide high quality products to our patients, that are safe and effective. Each of us at Aurinia own Quality, and we proactively integrate Quality into everything that we do. Exceptional quality and regulatory compliance are essential to our business, and "We Care" so that patients can take our drugs with confidence.

Our strategy leverages the skills and knowledge of our expert team and our deep experience in principled drug development and commercialization. Aurinia's working environment enables every individual to thrive in a professional atmosphere guided by our Culture Values:

Achieve together

Collaborate

Explore & build

Act responsibly

Together, we drive to change the trajectory of autoimmune disease for patients in need.

Position: Senior Director, Global Regulatory Affairs

Department: Regulatory Affairs

Location: Rockville Office - Hybrid

Overview

This position will report to the Chief Medical Officer and will be responsible for developing, leading, and implementing regulatory strategies for new products, marketed product registrations as well as possible licensing opportunities In addition, this role will oversee all post-approval regulatory activities for commercial products and directs all global (including US) regulatory support and submissions for commercial products following initial approval. Additionally, the Senior Director will provide oversight of the regulatory function in the cross-functional advertising and promotional material review committee. This role will be the Global Regulatory Affairs lead and have all regulatory functions reporting to them.

Primary Responsibilities Create, implement, execute and be accountable for the regulatory strategy plan for the company asset and any new asset; Responsible for ensuring timely development of product operating plans.

Plans and directs projects and provides regulatory advice, leadership and consultation to cross-functional colleagues as well as members of the global regulatory team

Acts as the lead for interfacing with Health Authority review teams, facilitating approval of regulatory submissions and coordinates appropriate responses to Health Authorities with appropriate personnel and departments to resolve new or outstanding regulatory issues.

Organizes the planning, preparation and execution for meetings or teleconferences with Health Authorities (e.g., FDA, EMA).

Provide support for post-marketing commitments and inspections. Evaluate regulatory impact on marketed product and oversee appropriate submissions.

Provide leadership and oversight of the regulatory function in the cross-functional advertising and promotional material review committee. Provide advice to Commercial and Medical leadership considering business needs, US regulatory requirements, and internal policies and procedures

Qualifications Demonstrated interpersonal skills that include Aurinia's core values of Collaborate, Achieve Together, Explore and Build, and Act Responsibly

Minimum bachelor's degree (advanced degree preferred), preferably in a health/science field

Minimum of 10 years of pharmaceutical industry experience in new drug regulated product strategy and submissions; including working knowledge of FDA, EMA, Health Canada, and other contemporary Health Authorities laws / regulations / guidance applicable to registration and approval of drugs and devices.

Prefer At least 7 years in regulatory affairs with proven experience (successful filing and defense of major submissionsNDA / BLA / MAA) setting and executing strategy in pre-clinical, clinical, CMC, or marketed products regulatory; depending on the role of the position.

Working knowledge of relevant drug and device laws regulations and guidelines

Experience with direct interface with FDA Review Division and Office of Prescription Drug Promotion

Experience with reviewing advertising and promotional labeling with an understanding of applicable compliance requirements.

Solid working knowledge of US commercialization regulations and processes for pharmaceuticals and the ability to apply knowledge both strategically and operationally to commercial product regulatory issues

Excellent verbal, written, and presentation skills and the ability to work collaboratively

Excellent interpersonal and management skills

Ability to work independently as well as multi-task in a fast-paced atmosphere with multiple/changing priorities

Willing to travel, both domestic and internationally up to 20% percent of the time

Additional Information

All candidate information will be kept confidential according to EEO guidelines.