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Manager, Regulatory Affairs

Reference Number: 2778
Location: Southeast

Our client is a diversified healthcare company that is dedicated to improving care through a combination of branded products, generics, devices, technology and services.  They have asked us to assist them in their search for a Manager, Regulatory Affairs.

The Manager, Regulatory Affairs is responsible for the development of regulatory strategies for new and marketed products in preparation of compliant regulatory submissions required to market or modify the company’s products as well as the regulatory assessment of change control for approved ANDAs.  The incumbent will direct the preparation, review, and approval of submissions to FDA.  He/she will evaluate regulatory issues and provide accurate and timely recommendations and alternatives as needed.   This position supervises the activities and performance of direct reports in support of generic products.  The Manager, Regulatory Affairs provides them with guidance in the preparation of FDA submissions.

Major tasks and responsibilities will include:

  • Evaluates change controls and provides final regulatory assessment.
  • Reviews ANDAs, Amendments, Supplements, Annual Reports, Periodic Safety Update Reports, Control Documents, etc. for FDA submissions.
  • Coaches, mentors, and trains RA Specialists.
  • Provides them with guidance in the preparation of FDA submissions.
  • Leads the formulation of strategies to maintain approval and make changes to existing products and processes as needed.
  • Assesses change control documents for accuracy and/or determination of reporting category.
  • Provides regulatory guidance on complex issues to quality and manufacturing/ operations departments.
  • Reviews and approves Supplements, Annual Reports, Periodic Safety Update Reports, and e-processing activities prior to submission to FDA.
  • Critically reviews and approves documents for marketed products.
  • Oversees the preparation of original ANDAs and deficiency responses, and interacts with authorities to obtain product approvals.
  • Researches, prepares, constructs, reviews and submits documentation for regulatory product submissions.
  • Provides input to regulatory strategy, milestones and submission deliverables for the development of new Generic products.
  • Represents regulatory affairs on product development teams.
  • Determines and communicates product approval requirements.
  • Leads the development of strategies to support first to market commercial opportunities and minimize time to product launch.
  • Provides strategic and tactical guidance regarding submission requirements to support product approvals.
  • Leads ANDA project teams; provides regulatory guidance and ensures that plans and activities adhere to regulations and guidelines regarding submissions.
  • Manages the coordination, preparation, and submission of all sections of ANDAs, amendments and supplements to support the company timelines and strategy.
  • Assists in the overall management of projects within the department and acts as internal point of contact to other department.
  • Proactively identifies and addresses complex problems; proposes solutions and assists in developing solutions.
  • Analyzes work process and incorporates changes in schedule or deadlines; prioritizes multiple demands and competing priorities for productive use of time.
  • Interprets and enforces all department standards, policies, and operating procedure requirements.
  • Manages and develops staff.  Hires, trains and manages performance of staff; develops professional skills and understanding of business, industry practices; encourages participation in professional development and industry education programs.

We seek candidates with the following qualifications:

  • Bachelor’s degree in scientific or healthcare discipline.
  • 7-9 years regulatory affairs experience; 1-2 years previous leadership experience preferred.
  • Experience with generic products.
  • Experience interfacing with the FDA.
  • Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
  • Knowledge of FDA and ICH guidelines pertaining to ANDA submissions and change control.
  • Proficient computer literacy.
  • Strong attention to detail.
  • Excellent oral and written communication skills.
  • Ability to manage multiple priorities.
  • Ability to execute effective decision-making, planning and project management.

 

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2778. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.