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.
- At InGeneron Inc, Houston, TX
- Benefits offered: 401K, Dental, Life, Medical, Vision
- 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 email@example.com or contact us at any time if you have questions.