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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Regulatory Affairs Manager

Description

  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Interpret regulatory rules or rule changes and ensure through training programs or other appropriate communication tools that they are understood and followed by everyone and included in updated corporate policies and procedures.
  • Develop and deliver as appropriate annual Regulatory training program to all employees
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Write or update standard operating procedures, work instructions, or policies.
  • In partnership with the Senior Regulatory Affairs team, communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Compile and maintain regulatory documentation databases or systems.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device/product changes or labeling changes.
  • Participate in internal or external audits.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.

Required Skills & Background

  • 4 to 7 years pharmaceutical or medical device industry regulatory affairs required.
  • Experience with maintaining a variety of regulatory affairs database systems.
  • Demonstrated success in designing and delivering regulatory affairs training programs.
  • At least 3 plus years of actual experience with filing required regulatory affairs documents with the FDA and/or appropriate government agencies.
  • Hands on experience with FDA interactions and understanding all processes associated with FDA interactions.
  • Proven track record of project management skills
  • Excellent interpersonal skills, ability to manage conflicting points of view and negotiate an appropriate resolution to issues while ensuring compliance with applicable regulations.
  • Good communications skills, both written and verbal.  Must be able to convey scientific and sometimes complex issues in a clear concise manner to ensure understanding across a very diverse employee population.

Education

  • Bachelor’s degree required however a Bachelor’s degree in a scientific field is preferred. RAC preferred.

COMPETENCIES:

  • Analytical
  • Database Management
  • Attention to Detail
  • Problem Solving
  • Building relationships
  • Diplomacy
  • Teamwork