Global Regulatory Affairs Manager

Job description

New World Medical is seeking a highly motivated, energetic professional capable of working effectively in a fast-paced environment to join and shape our Regulatory Affairs Department. The Global Regulatory Affairs Manager will be responsible for creating the strategy and systems required to support our global regulatory activities for new product registration and life-cycle maintenance.  This position will report to the Quality Assurance and Regulatory Affairs Director.  

The Regulatory Affairs Manager understands the requirements of regulatory regulations and will have experience navigating technical regulatory issues impacting product design and engineering. The regulatory department works in a highly collaborative manner and the successful candidate will have developed a comfort level working closely with engineers, regulatory authorities, and business development to identify and address complex issues bearing on in-market product improvement and pre-market product development.

 

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

  • Responsible for creating regulatory systems and procedures that meet the necessary regulatory requirements
  • Responsible of mentoring and managing the Regulatory Affairs department resources and ensuring expertise is assigned to meet company goals and objectives
  • Undertake people management responsibilities to the direct reports to this role, including but not restricted to, generating training and development plans, carrying out performance appraisals and dealing with performance related issues
  • Provide coaching and support to direct reports in their day to day roles and act as a point of escalation where necessary for specific issues that may arise
  • Ensure that products are appropriately registered and maintained in all countries where they are for sale
  • Understand regional laws, regulations, guidance, and global regulatory requirements while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards
  • Perform regulatory intelligence to track regulatory developments for changes to laws and regulations and create awareness of anticipated impact to New World Medical business
  • Provide US and international regulatory guidance and support regarding product development and evaluation in current and future markets where New World Medical presently operate
  • Manage project timeline, planning and preparation and submission of marketing applications to support regions where product is distributed
  • Execute optimized timelines, determine data requirements and operational compliance protocols for obtaining approvals for manufacturing operations, product launch and post-launch product evolution
  • Participate on interdisciplinary teams in establishing global regulatory strategy
  • Manage and prepare US and international regulatory file developments and submissions.
  • Provide regulatory support and development to team members
  • Act as a main point of contact for specific projects and serve as regulatory representative. The candidate will need a thorough understanding of commercial plans in order to provide insights on the feasibility for market entry
  • Participate in international health authority meetings, as required
  • Communicate with regulatory consultants regarding product development plans

KNOWLEDGE, SKILLS AND ABILITIES:

  • Regulatory Affairs Certification (RAC) or Masters in an applicable Regulatory discipline
  • Experience with global registration matters including an in-depth knowledge and understanding of the Regulatory environment. International regulatory experience preferred
  • Strong scientific/technical writing ability
  • Experience developing and managing teams and projects
  • Experience in a high- growth, fast paced organization
  • Collaborative and proactive team player with ability to quickly gain fluency in new subject areas
  • Strong organizational, time management and project management skills with attention to detail
  • Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions

Requirements

EDUCATION AND EXPERIENCE:

  • B.A./B.S. or M.S. in Science, or a related discipline
  • Minimum 3-5 years industry experience in Regulatory Affairs or related discipline
  • Working knowledge of regulations and the ability to understand and interpret law and regulations
  • Experience preparing and submitting regulatory applications to government agencies
  • Strong written and verbal communication skills

New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.