BESTMSLs

Vice President, Regulatory Affairs

Job ID 2022-1797
Job Locations
US-DC
Category
Vice President, Regulatory Affairs

Overview

Client (CLIENT) is a regulatory-driven product development company and the Vice President, Regulatory Affairs provides senior leadership to the Regulatory Affairs department to further grow and develop a high-performing regulatory function that provides comprehensive expert-level regulatory strategy and operational support for CLIENT Partner companies development programs

Responsibilities

RESPONSIBILITIES:

  • Serves as strategic lead for regulatory affairs and regulatory operations programs on all size programs for CLIENT. Establishes effective strategies to help CLIENT Partner companies navigate complex regulatory requirements and oversees high quality and effective regulatory operations to achieve product development goals consistent with CLIENT Partner company objectives.
  • Serves as liaison between CLIENT partner companies, CLIENT senior management, Program Team Leaders and Regulatory Program Leads on matters related to regulatory affairs and works toward the development of CLIENT company principles to achieve long-term objectives in creative and effective ways.
  • Develops effective regulatory strategies, provides regulatory functional area operational, technical, and project management expertise, and other relevant expertise as qualified by training and experience.
  • Provides leadership to a team of highly experienced regulatory professionals who fulfill the role of Regulatory Program Lead on complex product development programs.
  • Works to develop robust and scalable procedures within the Regulatory Affairs department aligned with the company objectives.Manages outsourcing and hiring for regulatory affairs department.
  • Serves as regulatory lead for all quality systems established for department, including department standard operating procedures (SOPs) and other standards relating to regulatory operations procedures.
  • Develops and provides/oversees regulatory affairs and operations forums and training.
  • Keeps abreast of current regulatory knowledge, trends, and developments in the US, Canada, Europe, and emerging markets, as needed.
  • Serves as a regulatory affairs liaison with CLIENT internal groups.
  • Manages CLIENT business development efforts for regulatory affairs, regulatory operations, and regulatory clinical support programs, including program strategy, proposal, and budget development. Leads contract and budget department discussion efforts.
  • May recommend course of action on management and human resources matters.
  • May participate in independent quality assurance activities for CLIENT as determined necessary as part of the CLIENT Quality Management System.
  • Participates in Regulatory Health Authority inspections with assistance from CLIENT Senior Management.
  • May perform other duties as assigned by CLIENT Senior Management.

Qualifications

QUALIFICATIONS:

  • Bachelor's Degree, preferably in science or healthcare discipline.
  • Advanced degree highly preferred.
  • 20 years or more work experience in a biopharmaceutical regulatory affairs environment. Expertise in a scientific, medical, clinical, or related field preferred.
  • 20 years or more experience in managing regulatory programs which includes experience in project management, communication skills, planning, organization, and business development.
  • 10 years or more of line management experience.
  • 5 years or more experience in budgeting programs and managing contractors/consultants/Service Providers/vendors along with their respective contracts and budgets.
  • Must have strong ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining positive results in a regulated environment.
  • Extensive knowledge of regulations relevant to drugs or biologics in the US, Europe, and Canada including US FDA and ICH CTD guidance for drugs and biologics.
  • Extensive knowledge and working experience of electronic common technical document (eCTD) criteria per US FDA regulations and ICH guidelines.
  • Comprehensive understanding of biopharmaceutical drug development process.
  • Must have excellent leadership and team-building skills, possess strong negotiating skills, and the ability to communicate effectively in both oral and written modes.

ORGANIZATIONAL RELATIONSHIPS:

  • DIRECT REPORTS: 0 – 5 individuals
  • Frequent interaction with internal and external consultants, CLIENT senior management, CLIENT Program Team Leads and CLIENT Partners.
  • Frequent interaction with internal and external program teams as a regulatory leader.
  • Frequent interaction with FDA, and/or other Regulatory Health Authority interactions.
  • Interaction concerning contract and budget negotiations.
  • Interaction concerning CLIENT Partner audits and Regulatory Health Authority inspections.

PHYSICAL REQUIREMENTS:

Position requires substantial use of telephone and face-to-face interactions. Position also requires extensive computer usage involving repetitive motions with fingers. Willingness to travel up to 10%, depending on assigned responsibilities.

 

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this position.

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