Senior Director, CMC Global Regulatory Affairs
Liquidia Corporation21 hours ago
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OnsiteFull-timeSenior
Summary
Liquidia Corporation is seeking a Senior Director, CMC Global Regulatory Affairs to lead regulatory CMC development, registration, and compliance activities from early development through commercialization, with the option to work remotely or from Research Triangle Park, North Carolina.
About the Role
As the Senior Director, CMC Global Regulatory Affairs, you will lead the development of CMC and device regulatory submission strategies, assess global regulatory filing requirements, develop Quality by Design (QbD) strategies, conduct risk assessments, prepare CMC sections of regulatory submissions, interface with regulatory agencies, and maintain knowledge of relevant regulations and guidelines.
About You
Required:
- Bachelor’s degree in chemistry, biochemistry, engineering, life sciences or related field.
- Minimum of 12 years of CMC regulatory or related experience in the pharmaceutical industry.
- Demonstrated experience to define and execute CMC regulatory strategies with minimal oversight.
- Strong knowledge of drug development and life cycle management concepts.
Preferred:
- Advanced degree in a relevant field.
- Small molecule experience.
- Understanding of pharmaceutical QbD concepts and techniques.
- Excellent knowledge of FDA and ICH requirements and guidelines.
Benefits
- Competitive compensation package including base salary and commission.
- Comprehensive benefits package including Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off.
Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology. Liquidia has developed YUTREPIA™ (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Liquidia is also developing L606, an investigational liposomal formulation of treprostinil administered twice-daily with a short-duration next-generation nebulizer, for use in North America. The subsidiary Liquidia PAH provides for the commercialization of pharmaceutical products to treat pulmonary disease, such as generic Treprostinil Injection.
Morrisville, NC