Allergan Assoc Dir, Regulatory Affairs CMC (Biologics) in Irvine, California

Assoc Dir, Regulatory Affairs CMC (Biologics)

Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/6161/other-jobs-matching/location-only

Aug 01, 2018Post Date

181831Requisition #

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

This position will independently provide tactical and strategic leadership on complex CMC projects within the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) organization by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and device/drug combination products.

Main Areas of Responsibilities

  • Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms. Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

  • Guide and influence technical groups in areas of product development and lifecycle enhancement. Participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc).

  • Responsible for negotiating and decision making with regulators and stakeholders with complex and high-risk projects.

  • Provide direct or indirect supervision of individuals including mentoring, performance management and staffing decisions.

  • Represent Allergan externally at appropriate industry associations. May act as primary contact with regulatory authorities including the planning and leadership of meetings. May participate in management of budgets.

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Requirements

  • Experience in a pharmaceutical manufacturing facility/development laboratory preferred.

  • Develop and implement regulatory strategy aligned with business strategy. Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.

  • Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions.

  • Implement policies to ensure ongoing compliance of regulatory requirements.

  • Participate in Due Diligence activities

  • Interpret, apply and implement global regulations to CMC projects and prepare CMC regulatory submissions.

  • Actively participate in project team meetings and provide leadership in meeting submission goals

  • Identify and manage resolution to routine and complex issues including regulatory risk and provide risk/benefit strategies

  • Represent RA CMC in preparation meetings with Health Authorities

Preferred Skills/Qualification

  • Global responsibility for regulatory submissions

  • Responsible for support of global registrations

  • Sound basis of Scientific (Training/Communications) knowledge in multiple areas

  • Expert knowledge of regulations, and experience with interpretation and application

  • Excellent written and verbal communication, presentation, and facilitation skills

  • Strong negotiation skills and significant experience in interacting with regulatory authorities

  • Risk identification and problem solving skills

  • Demonstrated ability to lead, mentor, and develop others for future growth and development

  • Established relationships with regulatory authorities

  • Ability to travel

Education

  • B.S. required in related scientific discipline with a minimum of 11 years of regulatory experience, including managing people or projects.

  • MS degree and 9 years of regulatory experience.

  • PhD and 6 years of regulatory experience.

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Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.