Director, Regulatory Affairs

SUMMARY

Responsible for proactively executing on regulatory affairs activities both within and outside the U.S. including, but primarily in the US: (i) executing regulatory interactions, (ii) providing project regulatory interpretation, strategy and guidance, (iii) coordinating regulatory activities handled by vendors and/or CRO’s, and (iv) anticipating and guarding against regulatory risks facing the Company.

ESSENTIAL FUNCTIONS

  • Partner with health authority project managers and review teams to represent their perspective in the Company.
  • Develop regulatory strategy for development and commercial projects.
  • Provide regulatory guidance and support to various departments including Clinical Research, Manufacturing, Commercial and Business Development.
  • Analyze regulatory history and competitor information to provide regulatory intelligence across relevant therapeutic areas and indications.
  • Review promotional and non-promotional materials for marketed products, and lead the Medical-Legal-Regulatory Review process
  • Coordinate project regulatory operations services.
  • Manages, drafts, and aids in securing internal approval of FDA meeting requests and briefing books.
  • Manages labeling documents, including preparing package inserts, as well as aiding in quality control of labeling submissions.
  • Responsible for managing the compilation, submission and maintenance of INDs, NDAs, amendments and supplements.
  • Support and participate in the Company’s due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.

SUBORDINATES

None; but will manage a network of consultants and vendors.

JOB REQUIREMENTS

Technical Skills/Knowledge

  • 7+ years of regulatory experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
  • Experience in working with development project teams in a regulatory leadership role.
  • Experience with FDA regulations and their impact across the entire development cycle including promotion of pharmaceutical products and labeling.
  • Experience across multiple therapeutic areas is a plus.
  • Ability to provide strategic and operational guidance across all levels of the company and external vendors.

Independence/Accountability

  • Normally receives no instructions on routine work.
  • Receives detailed instruction on new assignments only and determines next steps with guidance.
  • Define and review goals and objectives and inform management team of changes in objectives and timelines.
  • Must be a self-starter, resourceful and able to participate in a highly collaborative, team-oriented environment.
  • Must be able to handle, prioritize and follow through on a high volume of work, including the ability to anticipate and manage changing priorities and timelines.
  • Must have a strong commitment to corporate compliance.Must be able to work virtually, both as a member of teams and independently.

Problem solving

  • Has the ability to work on complex problems in which analysis of situations requires an in-depth evaluation of various factors.
  • Suggests and implements solutions to problems.

Leadership Activities

  • Expected to assist others with problem solving.
  • Proposes ideas and presents data within own group.
  • Participates in interdisciplinary team meetings.
  • Is accessible to others for technical advice.
  • Highest personal integrity; committed to ethics and scientific standards
  • Ability to influence those over whom there is no immediate supervisory capacity to achieve objectives
  • Ability to interface with internal customers and stakeholders, industry contacts, and consultants to accomplish corporate objectives

Communication Skills

  • Excellent communication skills, both oral and written.
  • Must work well with others.
  • Actively participates in own team meetings.
  • Assists other departments as necessary.

Customary Education and Experience

  • B.S. in life sciences or chemistry discipline
  • Additional regulatory education and/or certification is a plus.
  • Some travel required.

PHYSICAL DEMANDS

  • Physical demands consistent with working in an office and laboratory setting.

WORKING CONDITIONS

  • Office and virtualsettings
  • Moderate noise level
  • Flexible hours.
  • May be required to work on off hours and weekends

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc