Senior Manager Regulatory Affairs (m/f/x) I Bayern
package negotiable
Bayern

Senior Manager Regulatory Affairs (m/f/x) I Bayern

Our client is seeking a talented individual to fill a key position within their organization. As a Senior Manager in Regulatory Affairs Strategy, you'll have the opportunity to make a significant impact by driving forward their European regulatory initiatives. This role calls for a proactive individual with a solid background in regulatory affairs, strong leadership abilities, and a genuine enthusiasm for shaping the regulatory landscape.


Responsibilities:

  • Develop and execute regulatory strategies aligned with company objectives
  • Oversee the design and execution of clinical studies
  • Lead the preparation, submission, and monitoring of regulatory applications in both the EU and USA
  • Ensure compliance with relevant regulations and guidelines through effective medical writing oversight
  • Mentor and empower a team of professionals in Regulatory Affairs and Drug Development
  • Foster collaborations with external service providers, particularly CROs, to optimize regulatory processes
  • Provide regular updates on project progress and regulatory status to senior leadership and executive management
  • Drive the development of regulatory strategies to achieve our goals in line with the company's vision
  • Collaborate closely with cross-functional teams, including Quality Assurance, to achieve regulatory objectives

Requirements:

  • Bachelor's degree in a scientific discipline
  • Minimum of 5 years of experience in regulatory affairs, with a focus on guiding products through clinical development
  • Experience in team management and development preferred
  • Strong understanding of EU and FDA regulatory processes and requirements
  • Proven track record in shaping EU regulatory strategies
  • Excellent negotiation skills and ability to communicate effectively with stakeholders at all levels
  • Direct experience in interacting with national regulatory agencies and leading agency meetings
  • Fluent in written and spoken English

Benefits:

  • Opportunity to specialize in either Development or Commercial aspects of our pipeline
  • Hybrid working model with the flexibility for remote work up to 40%
  • Exciting new role offering the chance to contribute to our growth and success
  • Generous annual leave allowance of 30 days

Interested in joining the company?

Contact Details:
Email: s.revesz@sciproglobal.de
Tel: 0049 (0) 89/ 26 200 311

We look forward to receiving your application!

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