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Regulatory Affairs Leader

Reference Number: 2918
Location: MA

Our client is an international healthcare company.  They have asked us to assist them in their search for a Regulatory Affairs Leader.

The Regulatory Affairs Leader may be involved in pre or postmarket duties or both.  This position provides subject matter expertise and works with a team of RA professionals to ensure the company establishes best practices in premarket & postmarket for RA, and ensures accurate & optimal submission of regulatory medical product clearance files & postmarket reports that meet the requirements of the region or country.

Major tasks and responsibilities will include:

  • Files/Maintains regulatory deliverables.
  • Analyzes & communicates changes and proposed changes to country regulations through Regulatory Intelligence and implements strategies.
  • Supports local regulatory authority / notified body inspections as required.
  • Educates, trains, & advises company professionals to ensure compliance with regulatory requirements.
  • Coaches and mentors other RA professionals.
  • Creates regulatory compliance/project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate, timely input is provided for submissions.
  • Communicates with Product RA resources to establish regulatory requirements, including clinical trial data.
  • Provides RA support as needed to clinical studies to ensure regulatory requirements are met.
  • Partners with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required.
  • Acts as liaison with external regulatory reviewers to gain rapid approval of submissions.
  • Works with appropriate Product RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license.
  • Supports regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes.
  • Reviews new reportable adverse events for country reportability.
  • Prepare Regulatory Authority responses to inquiries; works with the P&L to ensure accurate response.
  • Reviews field action information to determine if reportable in local country.
  • Supports regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.
  • Acts as liaison with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.
  • Provides evidence of official closure of postmarket actions to the P&L.
  • Monitors external information for incidents or issues that may involve product; communicates information internally in a timely manner.

We seek candidates with the following qualifications:

  • Bachelor's Degree and a minimum of 3 years of experience in the pharmaceutical or biotechnology industry or with regulatory agencies; Or minimum of 7 years of progressive regulatory affairs experience in the pharmaceutical or biotechnology industry or with regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls.
  • Ability to prioritize, plan & evaluate deliverables to established strategic goals.
  • Proven application of analytical skills in a regulatory environment.
  • Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
  • Strong problem solving and negotiation skills.
  • Ability to work well independently & in a team setting.
  • Prior experience using spreadsheet and presentation software.
  • IND, NDA or related submission experience.
  • Regulatory Affairs Certification (RAPS).
  • Demonstrated experience interfacing with regulatory agencies and standards bodies.
  • Knowledge of Quality Management Systems (QMS).
  • Experience with working across cultures/countries/sites.
  • Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
  • Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies.
  • Experience with adverse event reporting and recalls.
  • Orphan drug or generics experience.

 

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 2918. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.