Director of Clinical Regulatory

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Why work here?

“Environment where you can work independently in a positive environment, creating and executing new ideas is encouraged!” 

Manage and lead strategic and operational aspects of regulatory compliance to realize product development objectives.

 

Duties and Responsibilities

  • Develop, implement and manage regulatory strategies and tactics for effective and expeditious approvals and commercialization of products.
  • Be the lead regulatory strategist/implementer and point person interacting with the FDA, EMEA and other regulatory authorities.
  • Monitor, advise, and ensure that the company follows global regulatory affairs and pharmaceutical compliance initiatives, trends, and requirements that impact the development and commercialization processes.
  • Participate in formulation of strategies to optimize approvals, competitive positioning, and global opportunities of product candidates based on a broad understanding of regulatory requirements.
  • Lead cross-functional teams in preparation of regulatory documents.
  • Contribute regulatory affairs expertise to assessment of new development projects.

 

Employment Type

  • Full-time
  • At InGeneron Inc, Houston, TX
  • Benefits offered: 401K, Dental, Life, Medical, Vision

Qualifications

  • Excellent oral and written communication skills.
  • Bachelor’s degree or higher in biomedical or life sciences
  • Previous experience as a Clinical Project Manager in a CRO (min 6years)
  • Previous experience within Rare Diseases
  • Ability to work from home
  • In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Broad protocol knowledge; therapeutic knowledge desired
  • Strong understanding of Clinical Research industry and the relevant environments in which it operates
  • In-depth knowledge of statutory requirements governing development of company products
  • Demonstrated ability to formulate and implement regulatory strategy.
  • Ability to successfully work to reach company goals in an environment in which a wide degree of creativity and latitude is available.

 

 

Please e-mail your resume to careers@ingeneron.com or contact us at any time if you have questions.