Director of Clinical Regulatory

Page Header Image

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.

 

 

About InGeneron

InGeneron was formed to innovate cell-based technologies for healthcare, veterinary and life science research. InGeneron’s advanced cell separation technologies enable preparation of adipose-derived regenerative cells, including stem cells, that have the potential to aid physicians and veterinarians in the treatment of a number of diseases, orthopedic injuries and cosmetic procedures. InGeneron is a privately held company, developing its own products for multiple markets and expanding its reach through licensing agreements. Its research and development capability span the disciplines of biomedical engineering, cellular as well as molecular biology, and pharmacology.

 

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