Director Regulatory Affairs - CMC - Rockaway, NJ | Biospace
Get Our FREE Industry eNewsletter

Director Regulatory Affairs - CMC

Allergan, Inc.

Apply
Location:
Rockaway, NJ
Posted Date:
6/22/2017
Position Type:
Full time
Job Code:
163531
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
CMC, Director, Regulatory Affairs,

Job Description


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 pharmaceuticals and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.

Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

Join one of the world’s fastest growing pharmaceutical companies!

At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.

Position Description

This Director, Regulatory Affairs CMC 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. 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. Participate in Due Diligence activities. Support the Executive Director in managing the department (e.g. contactor time keeping, employee onboarding) and completing departmental initiatives (e.g., development of departmental work processes).

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.
•   Key day-to-day activities will include the preparation of CMC regulatory submissions that meet global regulatory requirements, attending project teams or oversight committees, and representing the company during communications and meetings with health authorities.
•   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).
•   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. Responsible for negotiating and decision making with regulators and stakeholders with complex and high-risk projects.
•   Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
•   Provide direct or indirect supervision of individuals including mentoring, performance management and staffing decisions.
•   Support the Executive Director in managing team-related efforts (e.g. contactor time keeping, employee onboarding, development of departmental processes).

Requirements


•   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.
•   Proficiency with common office software applications.

Preferred Skills/Qualifications

•   International Global experience/exposure preferred.
•   Experience in a pharmaceutical manufacturing or testing facility/development laboratory preferred.

Education

•   BS degree with 10+ years pharmaceutical or related experience and 8+ years of Regulatory Affairs / Regulatory CMC strategy perferred.
•   PhD/MS 6+ years pharmaceutical or related experience and 4+ years Regulatory Affairs/Regulatory CMC experience preferred.