Director, Regulatory Affairs

19 Nov, 2020

Jobs

Director, Regulatory Affairs

Trevena, Inc.
Chesterbrook, PA

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

Learn more here

Job posted: 2020-11-19