Regulatory Affairs Manager (Remote)

27 Sep, 2020

Jobs

Regulatory Affairs Manager (Remote)

Eversana
Remote

Overview

THE POSITION:

The most important aspect of the position of the Regulatory Affairs Manager is being responsible for managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This person will function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. This person will also be client facing and be responsible for managing multiple regulatory deliverables for internal and external clients.

 

OUR CULTURAL BELIEFS

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others.

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

Own It I hold myself and others accountable for results.

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

  • Managing the regulatory aspects of projects, including complex applications submitted to various regulatory agencies
  • Ensuring that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements, including publishing in eCTD format
  • Developing strategic regulatory approaches for projects, as appropriate with some oversight
  • Authoring regulatory documents and submissions, including regulatory assessments, 510(k)s, De Novos, Pre-Submissions, Technical Files, INDs, CTAs, NDAs, BLAs, MAAs, etc.
  • Planning and conducting formal meetings and teleconferences with regulatory authorities
  • Provides Submission Management support to plan, track, and manage complete regulatory submissions
  • Coordinates regulatory meetings by assisting with agenda, minutes or action items
  • Provides guidance on organization and management of regulatory files and records
  • All other duties as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

 

EXPECTATIONS OF THE JOB:

  • Managing, training and mentoring regulatory associates and/or quality specialists
  • Ability to handle multiple priorities across a variety of external clients
  • Management of multiple deliverables simultaneously
  • Travel – Up to 50% required (may occasionally exceed 50%)
  • Hours – Minimum 40 hours/week

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

 

  • Bachelor’s degree in a related discipline with a minimum of 5 years regulatory affairs experience is preferred; medical device and biopharma industry experience is strongly preferred
  • Master’s degree in a related discipline with 2 years regulatory affairs experience is also acceptable, assuming experience supports minimum job qualifications
  • Incumbent must be able to operate in a highly structured environment and manage multiple projects simultaneously while providing options to EVERSANA clients that work to keep the client in compliance with all appropriate regulations
  • Working knowledge of the product development lifecycle
  • Strong experience successfully publishing and submitting a variety of submissions in eCTD format
  • Working familiarity with regulatory agencies, such as FDA, EMA, TGA, Health Canada and/or Notified Bodies. Must have at least domestic (US FDA) regulatory experience.
  • Strong regulatory writing ability, including regulatory assessments, 510(k)s, De Novos, Pre-Submissions, Technical Files, INDs, CTAs, NDAs, BLAs, MAAs, etc.
  • Strong Project Management skills; knowledge and implementation of process and planning best practice
  • Excellent communication and interpersonal skills supporting a high level of professionalism
  • Experience managing and/or mentoring technical resources is highly desired
  • Ability to handle multiple priorities across a variety of external clients
  • Ability to handle technical resources at a variety of levels
  • Technical knowledge
  • Managerial experience
  • Extremely detail-oriented
  • Organizational skills
  • Multiple priorities with tight timelines

 

 

PREFERRED QUALIFICATIONS:

  • Previous experience in the medical devices and biopharmaceutical industry is strongly preferred
  • International (OUS) regulatory experience is a plus

 

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

 

Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

Learn more here

#LI-REMOTE

#LI-LB1

Job posted: 2020-09-27