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Title:  Regulatory Writer Director

Job ID:  72605
Country:  Switzerland
City:  Geneva
Professional area:  Scientific Regulatory Affairs
Contract type:  Permanent
Professional level:  Experienced
Location: 

Geneva, GE, CH, 1202

 

We’re JTI, Japan Tobacco International and we believe in freedom. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our consumers to choose from. It’s how we’ve grown to be present in 130 countries.

But our business isn’t just business. Our business is our people. Their talent. Their potential. We believe when they’re free to be themselves, grow, travel and develop, amazing things can happen for our business

That’s why our employees, from around the world, choose to be a part of JTI. It is why 87% of employees feel happy working at JTI. And why we’ve been awarded Global Top Employer status, eight years running

So when you’re ready to choose a career you’ll love, in a company you’ll love, feel free to #JoinTheIdea. 

Learn more: jti.com

 

 

Regulatory Writer Director

 

 

What this position is about - Purpose:

Reporting to the VP of Regulatory Science and under their leadership, Regulatory Writer Director is responsible for leading the strategy for global regulatory submission content and organization. She / He will have oversight of the content included in all internal documentation provided in support of regulatory submissions. The individual will continuously assess factors that may impact or change the direction of a regulatory submission with a focus on ensuring the competitiveness of JTI's portfolio.

 

What will you do - Responsibilities:

  • Working with the Regulatory Science VP and other team members, oversee Regulatory Science submission development:
    • Working closely with stakeholders and external vendors, she / he develops regulatory documents for submission to regulatory agencies in accordance with relevant, specified regulatory guidelines and requirements and in adherence with Program timelines
    • Leads, manages, and coordinates all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally
    • Leads the progression of documents through the review process, including conducting comment resolutions meetings
       
  • Accountable for providing strategic direction on regulatory document preparation challenges and monitoring future regulatory submission developments:
    • Provides input to Regulatory Science operations activities (internal and external meetings, investigator meetings, discussions with Contract Research Organization / vendors / third parties, budgets)
    • Anticipates and reports on regulatory writing industry trends
    • Benchmarks Regulatory Science submission organization and content activities
       
  • Influences and provides awareness to other related internal business functions:
    • Confirms Regulatory Science strategic priorities, deprioritizes less important deliverables
    • Identifies and communicates pertinent Program and regulatory priorities to JTI's cross-functional teams
    • Accountable for developing and having total oversight of JTI's internal processes, including the development of SOPs and policies, study oversight, and training

 

Who are we looking for - Requirements: 

  • Degree (Science) preferably to PhD or professional doctorate (e.g., MD, DVM, PharmD) level
  • 6+ years regulatory writing experience or other relevant Pharma or medical device experience combined with scientific and regulatory knowledge required
  • Experience as a regulatory medical writer with a strong understanding of ICH/GCP is preferred
  • Expert knowledge of biostatistics principles
  • Experience working in multinational and multi-cultural environments and in a highly regulated industry is a must
  • Excellent English communication skills (both written and oral) are a must
  • Excellent inter-personal and business relationships skills, multi-cultural sensitivity, good negotiation skills
  • Excellent team player, willing and able to coach, develop and motivate others

 

 

What are the next steps – Recruitment process:

Thank you very much for your interest in the role. You are welcome to apply.

 

 

 


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