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Senior Manager, Regulatory Affairs

Company: Allergan
Location: Irvine
Posted on: July 14, 2019

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 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

Plans and prepares complex medical device regulatory

submission documents for US, Canada, and international regulatory filings.

Utilizing detailed, in-depth understanding of medical device regulations, leads

and participates in global regulatory teams, interprets regulations, and

provides regulatory guidance.

Main Areas of Responsibilities



  • Submissions, development and lifecycle

    maintenance




    • Plans and prepares complex

      regulatory documents for US and international product approvals with

      minimum supervision.

    • Resolves submission problem

      areas with team or direct supervisor.
    • Prepares clear and accurate

      internal and external complex administrative and scientific documents,

      under minimal supervision.

    • Prepares complex expository and

      technical documents, logically constructed and comprehensive in content.
    • Prepares documentation that is

      complete, accurate, and on time.
    • Manages post-approval projects

      not requiring a global core team. Plans and implements regulatory

      activities that support lifecycle management (e.g. Clinical Evaluation

      Report support, annual reports, changes, etc.)
    • Reviews labeling and packaging

      components to ensure accuracy and compliance with government regulations.

      Submits product labeling in compliance with legal/regulatory requirements

      and communicates planned/approved changes with operations, commercial,

      medical affairs and marketing.




      • Advisory

        responsibilities




        • Participates

          in global teams and provides regulatory strategy and guidance to global

          product development teams.
        • Under

          minimal supervision, develops US regulatory filing strategy. Works with

          international colleagues to develop filing strategies outside the US.
        • Critically

          reviews complex reports, validations, etc. for scientific merit and

          regulatory appropriateness. Works collaboratively with cross-functional

          team to resolve project issues.

        • Has

          recognized regulatory expertise and knowledge of regulatory requirements

          with ability to strategically interpret and communicate requirements.

        • Ensures

          planned device development activities comply with US and global regulatory

          guidelines, and, in cases where they do not, provides a critical analysis

          of the risks and issues with minimal supervision.
        • Ensures that teams and

          functional groups are provided with clear, constructive regulatory advice

          and intelligence to assist planning and issue resolution during product

          development and registration

          3. Communications and Business

          Support



          • Represents

            department on global project teams.
          • Establishes

            relationships with US colleagues as well as global regulatory team to

            ensure local RA activities are in line with global business priorities.

          • Develops

            professional relationships with Health Authorities, when required.

          • Interacts

            as appropriate with outside vendors, suppliers, contract research

            organizations, and others.

          • Conveys

            information on team timelines and status to supervisor.

          • Delivers

            presentations within the Company, as required.


          • LI-ML

            Requirements



            • Class III medical device

              experience required.

              Preferred

              Skills/Qualification



              • Experience with implantable

                medical devices preferred.
              • Analytical

                thinking and problem solving skills
              • Excellent

                written and verbal communication skills.
              • Good

                negotiation skills.
              • Ability

                to work well independently and with others.
              • Excellent

                organizational skills and attention to detail.
              • Ability

                to handle multiple projects simultaneously and maintain flexibility.
              • Experience

                with Adobe Acrobat, Excel, Power Point, and Word, and ability to learn new

                computer programs.
              • Ability

                to understand and use technical documents, such as regulations and

                guidance documents, as well as technical reports, in support of regulatory

                submissions.
              • Critical

                thinking skills and ability to follow-through.
              • In-depth

                knowledge of US medical device regulations as well as significant

                knowledge of Canadian and EU regulations.

              • Ability

                to demonstrate leadership in job performance by example.
              • Ability

                to function in a regulated environment and handle confidential data.
              • Ability

                to lead and motivate others.
              • Ability

                to meet deadlines; take initiative and make decisions within

                department/company guidelines.

                Education



                • Education equivalent to a BS

                  degree in a scientific field, plus 8 years' experience in regulatory

                  affairs; or

                • Education equivalent to a MS

                  degree in a scientific field, plus 6 years' experience in regulatory

                  affairs; or
                • Education equivalent to a PhD

                  degree in a scientific field, plus 4 years' experience in regulatory

                  affairs








Keywords: Allergan, Irvine , Senior Manager, Regulatory Affairs, Executive , Irvine, California

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